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| Name | Class |
|---|---|
| MacroGenics | INDUSTRY |
| Translational Breast Cancer Research Consortium | OTHER |
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The purpose of this study is to determine how well participants with stage II-III HER2-positive breast cancer respond to pre-operative treatment using one of two different combinations of drugs.
Drugs and Combinations used:
This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2 positive breast cancer.
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.
Participants will be randomized, which means randomly assigned, to one of two treatment arms. The treatment arms in this study and the names of the study drugs in each arm are:
Participants will receive study treatment for 12 weeks prior to surgery and will be followed for 10 years after surgery. After surgery, some participants will continue to receive the study drug margetuximab for a year in total, if they respond very well to the first 12 weeks of treatment with margetuximab.
It is expected that about 171 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.
The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab (Herceptin), and pertuzumab as part of a pre-operative treatment option for stage II-III HER2-positive breast cancer.
The U.S. Food and Drug Administration (FDA) has approved margetuximab (Margenza) for advanced HER2-positive breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel + Pertuzumab + Margetuximab | Experimental | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
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| Paclitaxel + Pertuzumab + Trastuzumab | Experimental | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (pCR) | Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Pathologic Complete Response in Hormone Receptor Positive (HR+) Subjects | In hormone receptor positive (HR+) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. |
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Inclusion Criteria:
Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm (in breast mass or axillary lymph node) determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible.
Centrally confirmed to have a low affinity CD16 germline genotype (FF or FV)
HER-2 positive by 2018 American Society of Clinical Oncology/College of American Pathologists criteria, as assessed by standard institutional guidelines (central testing is not required).
ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods according to standard institutional guidelines
Bilateral breast cancers are allowed as long as both cancers are HER2-positive (as defined in 3.1.2), or the contralateral cancer is a <1 cm, ER+ tumor.
Patients with multifocal or multicentric disease are eligible if the treating investigator hasdetermined the patient should be treated as HER2-positive.
Breast imaging should include dedicated ultrasound of the ipsilateral axilla. For subjects with a clinically positive axilla based on exam or imaging, a fine needle aspiration or core biopsy procedure will be performed to determine the presence of metastatic disease in the lymph nodes (though lymph node sampling procedure need not be resulted prior to patient's registration on trial, as long as all other eligibility are met).
Men and women (with any menopausal status) ≥18 years of age are eligible.
ECOG performance status 0 or 1
Required laboratory values demonstrating adequate organ function:
Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment start. Childbearing potential is defined as: those who have not been surgically sterilized and/or have had a menstrual period in the past 12 months
Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment.
Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible.
Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
Non-English-speaking patients are eligible but will be exempt from patient-completed questionnaires.
Willing and able to sign informed consent.
Willing to undergo breast biopsy for research purposes.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrienne Waks, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| MedStar Washington Hospital Center |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel + Pertuzumab + Margetuximab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2025 |
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| Pertuzumab | Drug | Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. |
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| Margetuximab | Drug | Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. |
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| Trastuzumab | Drug | Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
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| 12 weeks |
| Rate of Pathologic Complete Response in Hormone Receptor Negative (HR-) Subjects | In hormone receptor negative (HR-) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | 12 weeks |
| Residual Cancer Burden (RCB) Scores | Assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | 12 weeks |
| Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects | Among hormone receptor positive (HR+) patients, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. | 12 weeks |
| Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects | Among hormone receptor negative (HR-) subjects, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | 12 weeks |
| Dose-limiting Toxicities (DLTs) in theTMP Arm (Paclitaxel/Margetuximab/Pertuzumab) During the First 21 Days of Treatment | Among the subjects treated with TMP (Paclitaxel/Margetuximab/Pertuzumab), report the number of subjects with dose-limiting toxicities (DLTs) during the first 21 days of treatment, where 21 days equals one cycle of treatment. DLTs are defined in Section 5.4 of the protocol, with the specified toxicities and lab values categorized and graded according to CTCAE v5.0. | From first treatment to 21 days |
| Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment | Maximum grade of all treatment-related adverse events (TRAEs) according to CTCAE v5.0 during neoadjuvant treatment, recorded per patient per arm. Subjects with no TRAEs reported (Grade 0) and Grade 1 adverse events are combined into a single category because only adverse events of Grade 2 or more were consistently reported. | Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment. |
| Patient-reported Outcomes | Patient-reported outcomes for symptoms and quality of life (both physical and mental health) during neoadjuvant TMP and THP | From first treatment to 12 weeks |
| Event-free Survival Rate (EFS) | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Event-free Survival Rate (EFS) Patients With RCB 0 or 1 | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Event-free Survival Rate (EFS)Patients With RCB 2 or 3 | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Event-free Survival Rate (EFS) Patients Randomized to Neoadjuvant TMP | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Event-free Survival Rate (EFS) Patients Randomized to Neoadjuvant THP | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Event-free Survival Rate (EFS) -Patients With pCR | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Event-free Survival Rate (EFS) -Patients Without pCR | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) RCB 0 or 1 | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) RCB 2 or 3 | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) Patients Randomized to Neoadjuvant TMP | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) Patients Randomized to Neoadjuvant THP | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) Patients With pCR | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence ror death from breast cancer or up to 10 years |
| Recurrence-free Interval Rate (RFI) Patients Without pCR | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years |
| Overall Survival Rate (OS) | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Overall Survival Rate (OS) Patients With RCB 0 or 1 | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Overall Survival Rate (OS) Patients With RCB 2 or 3 | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Overall Survival Rate (OS) Patients Randomized to Neoadjuvant TMP | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Overall Survival Rate (OS) Randomized to Neoadjuvant THP | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Overall Survival Rate (OS) Patients With pCR | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Overall Survival Rate (OS) Patients Without CR | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | up to 10 years from definitive surgery. |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Brigham Cancer Center - Foxborough | Foxborough | Massachusetts | 02035 | United States |
| Dana-Farber at Milford | Milford | Massachusetts | 01757 | United States |
| Dana-Farber at South Shore Hospital | Weymouth | Massachusetts | 02190 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| UPMC Hillman Cancer Center - Arnold Palmer at Mountain View | Greensburg | Pennsylvania | 15601 | United States |
| UPMC Hillman Cancer Center - Arnold Palmer at Norwin | Irwin | Pennsylvania | 15642 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Washington Fred Hutchinson Cancer Care | Seattle | Washington | 98109 | United States |
| FG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Patients who received at least one dose of their assigned treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel + Pertuzumab + Margetuximab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. |
| BG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Clinical stage of primary breast cancer | Count of Participants | Participants |
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| Hormone receptor status of primary breast cancer | Count of Participants | Participants |
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| CD16A Genotype | The Fc-gamma RIIIA (CD16) stimulatory receptor is encoded by two alleles that differ at amino acid 158: a V allele (valine; higher affinity) and an F allele (phenylalanine; lower affinity) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologic Complete Response (pCR) | Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | Subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 117 to 116). | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Rate of Pathologic Complete Response in Hormone Receptor Positive (HR+) Subjects | In hormone receptor positive (HR+) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | Hormone receptor positive (HR+) subjects with hormone receptor positive (HR+) primary breast cancers who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Rate of Pathologic Complete Response in Hormone Receptor Negative (HR-) Subjects | In hormone receptor negative (HR-) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | HR- subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 43 to 42). | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Residual Cancer Burden (RCB) Scores | Assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | Subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 117 to 116). | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects | Among hormone receptor positive (HR+) patients, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. | Hormone receptor positive (HR+) subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects | Among hormone receptor negative (HR-) subjects, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review. | HR- subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 43 to 42). | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Dose-limiting Toxicities (DLTs) in theTMP Arm (Paclitaxel/Margetuximab/Pertuzumab) During the First 21 Days of Treatment | Among the subjects treated with TMP (Paclitaxel/Margetuximab/Pertuzumab), report the number of subjects with dose-limiting toxicities (DLTs) during the first 21 days of treatment, where 21 days equals one cycle of treatment. DLTs are defined in Section 5.4 of the protocol, with the specified toxicities and lab values categorized and graded according to CTCAE v5.0. | All subjects treated at least one dose of TMP (Paclitaxel/Margetuximab/Pertuzumab). | Posted | Count of Participants | Participants | From first treatment to 21 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment | Maximum grade of all treatment-related adverse events (TRAEs) according to CTCAE v5.0 during neoadjuvant treatment, recorded per patient per arm. Subjects with no TRAEs reported (Grade 0) and Grade 1 adverse events are combined into a single category because only adverse events of Grade 2 or more were consistently reported. | All subjects who received at least one dose of study treatment | Posted | Count of Participants | Participants | Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment. |
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| Secondary | Patient-reported Outcomes | Patient-reported outcomes for symptoms and quality of life (both physical and mental health) during neoadjuvant TMP and THP | Not Posted | From first treatment to 12 weeks | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS) | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS) Patients With RCB 0 or 1 | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS)Patients With RCB 2 or 3 | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS) Patients Randomized to Neoadjuvant TMP | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS) Patients Randomized to Neoadjuvant THP | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS) -Patients With pCR | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival Rate (EFS) -Patients Without pCR | The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) RCB 0 or 1 | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) RCB 2 or 3 | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) Patients Randomized to Neoadjuvant TMP | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) Patients Randomized to Neoadjuvant THP | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) Patients With pCR | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence ror death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Recurrence-free Interval Rate (RFI) Patients Without pCR | The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) Patients With RCB 0 or 1 | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) Patients With RCB 2 or 3 | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) Patients Randomized to Neoadjuvant TMP | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) Randomized to Neoadjuvant THP | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) Patients With pCR | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Rate (OS) Patients Without CR | The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error | Not Posted | up to 10 years from definitive surgery. | Participants |
Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paclitaxel + Pertuzumab + Margetuximab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. | 1 | 117 | 4 | 117 | 105 | 117 |
| EG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. | 0 | 54 | 1 | 54 | 46 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter related infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flashing lights | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vision decreased | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Belching | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Flu like symptoms | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized edema | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Localized edema | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Papulopustular rash | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Glucosuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Amenorrhea | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal inflammation | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nail discoloration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | CTCAE (5.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adrienne G. Waks, MD | Dana-Farber Cancer Institute | 617-632-3800 | adrienne_waks@dfci.harvard.edu |
| Sep 8, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| C000617981 | margetuximab |
| D000068878 | Trastuzumab |
| C000630669 | Ogivri |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Stage III |
|
| Negative (ER < 1% and PR < 1%) |
|
| FV |
|
| OG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
|
|
|
| OG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
|
|
|
| OG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
|
|
|
|
| OG001 | Paclitaxel + Pertuzumab + Trastuzumab | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
|
|
| Participants |
|
|
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
|
|