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The study did not meet the pilot feasibility endpoints and was formally closed to accrual prematurely on February 8, 2017.
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Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.
TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. Clinically, patients with TNBC have a poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because of the aggressive phenotype and due to observations that systemic chemotherapy offers significantly higher benefit in ER negative disease, current treatment guidelines from provincial and other organizations recommend that patients receive adjuvant systemic chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive independent of primary tumor size.
Currently, there is no world-wide standard recommended chemotherapy regimen for the management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region and institution.
As physicians do not know what the "best" treatment for patients is, genuine uncertainty ("clinical equipoise") exists. Physicians will choose between different "standards" in their personal practice, using idiosyncratic decision making processes, without the physician or the patient knowing the optimal option. This is not good for patients, physicians and society as a whole. Determining the optimal treatment remains an important medical issue for patients, physicians and society. This study will survey opinions on a novel method to allow comparisons of established standard of care prophylactic treatment using the "integrated consent model" as part of a pragmatic clinical trial and attempt to compare head to head standard chemotherapy regimens in patients with TNBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose dense AC-P | Active Comparator | Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) |
|
| Dose dense AC | Active Comparator | Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) |
|
| FEC-D | Active Comparator | FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose dense AC-P | Drug | (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC compared to the number of participants who after being approached subsequently agree to randomization. | One year |
| Participant Satisfaction | Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Complete Study Treatment | Percentage of participants who complete study treatment compared to the percentage who discontinue their treatment while on study (compliance) will be calculated using the sites chemotherapy treatment records and data from New Patient Registration. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hilton, Dr. | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K2H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28127659 | Background | Jacobs C, Clemons M, Mazzarello S, Hutton B, Joy AA, Brackstone M, Freedman O, Vandermeer L, Ibrahim M, Fergusson D, Hilton J. Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients. Support Care Cancer. 2017 Jun;25(6):1881-1886. doi: 10.1007/s00520-017-3580-4. Epub 2017 Jan 27. | |
| 30040817 |
| Label | URL |
|---|---|
| The Rethinking Clinical Trials (REaCT) website | View source |
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2 patients were approached for the study between August 30, 2016 and January 31, 2017, and both were enrolled and randomized. The study was closed to accrual prematurely on February 8, 2017, because it did not meet the pilot feasibility endpoints. According to the protocol, feasibility success is defined as over 50% of appropriate patients approached agree to participate, and over 50% of physicians who agree to participate approached patients for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Dense AC-P | Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) |
| FG001 |
| 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 | May 4, 2016 |
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| Dose dense AC | Drug | Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) |
|
|
| FEC-D | Drug | FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) |
|
|
| Hospitalization |
The number of participants with adverse effects requiring hospitalization |
| One year |
| Treatment Delays | The number of participants with adverse effects requiring treatment delays | One year |
| Hilton J, Stober C, Mazzarello S, Vandermeer L, Fergusson D, Hutton B, Clemons M. Randomised feasibility trial to compare three standard of care chemotherapy regimens for early stage triple-negative breast cancer (REaCT-TNBC trial). PLoS One. 2018 Jul 24;13(7):e0199297. doi: 10.1371/journal.pone.0199297. eCollection 2018. |
| Dose Dense AC |
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) |
| FG002 | FEC-D | FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) |
| COMPLETED |
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| NOT COMPLETED |
|
No participants were randomized to the Dose Dense AC group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Dense AC-P | Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) |
| BG001 | Dose Dense AC | Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) |
| BG002 | FEC-D | FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected. This was a feasibility study. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Sex variable was not collected. This was a feasibility study. | Count of Participants | Participants |
| ||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC compared to the number of participants who after being approached subsequently agree to randomization. | 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early. | Posted | Count of Participants | Participants | One year |
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| Primary | Participant Satisfaction | Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey | No participants were randomized to the Dose-dense AC group. | Posted | Count of Participants | Participants | One year |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Complete Study Treatment | Percentage of participants who complete study treatment compared to the percentage who discontinue their treatment while on study (compliance) will be calculated using the sites chemotherapy treatment records and data from New Patient Registration. | 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early. | Posted | Count of Participants | Participants | One year |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospitalization | The number of participants with adverse effects requiring hospitalization | There were no participants randomized to the Dose Dense AC group. | Posted | Count of Participants | Participants | One year |
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| Secondary | Treatment Delays | The number of participants with adverse effects requiring treatment delays | 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early. | Posted | Count of Participants | Participants | One year |
|
All-cause mortality was followed for approximately one year.
Serious Adverse Event (SAE) reporting is not required for this feasibility study, as per the protocol. Adverse events were not collected or reported. Secondary outcomes of hospitalization/treatment delays were collected by a variety of study staff on the case report forms, however they were not graded as adverse events. As per the protocol, there were no additional risks associated with this study as all arms are standard of care in this pragmatic clinical trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Dense AC-P | Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles) | 0 | 1 | 0 | 0 | 0 | 0 |
| EG001 | Dose Dense AC | Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | FEC-D | FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles) | 0 | 1 | 0 | 0 | 0 | 0 |
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The study did not meet feasibility and was terminated early. The study only involved 2 cancer centres. Physicians reported few TNBC patients in their clinics, and that it was challenging to tell a TNBC patient that the optimal chemotherapy regimen for their condition is unknown.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Hilton | Ottawa Hospital Research Institute | 613-737-7700 | 70170 | jfhilton@toh.ca |
| Mar 31, 2025 |
| Prot_SAP_000.pdf |
| 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 |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D005472 | Fluorouracil |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Completed study as planned |
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| Neutral |
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| Agree |
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| Strongly agree |
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| Not applicable |
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| Neutral |
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| Agree |
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| Strongly agree |
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| Not applicable |
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| Neutral |
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| Agree |
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| Strongly agree |
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| Not applicable |
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| Neutral |
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| Agree |
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| Strongly agree |
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| Not applicable |
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