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PI Decision
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This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.
Patients will fast 24 hours before and 24 hours after the administration of chemotherapy which will consist of doxorubicin plus cyclophosphamide every 2 weeks for four cycles followed by paclitaxel every 2 weeks for four cycles (dose-dense AC + T) or docetaxel (T) every 3 weeks for four cycles. Trastuzumab (H) and Pertuzumab (P) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pathological complete remission (pCR), adjuvant chemotherapy with doxorubicin (A) plus cyclophosphamide (C) every 3 weeks for four cycles will be given, followed by trastuzumab every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 negative breast cancer | Active Comparator | Doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel. |
|
| HER2 positive breast cancer | Active Comparator | Docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles. Pegfilgrastim after docetaxel. Surgery three to six weeks after completing the last docatexel. If additional chemotherapy is needed patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle then trastuzumab for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Response Rate at the Time of Surgery or at the Time of Biopsy | Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy. | 4-6 cycles (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI | The effect of short-term fasting on the toxicity of neoadjuvant chemotherapy in breast cancer patients according to the NCI common toxicity criteria (Version 4.03) | 4-6 cycles (up to 12 weeks) |
| Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Waypa, FNP | Research Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Regional Medical Center | Goodyear | Arizona | 85338 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnosed With HER2 Negative Breast Cancer | Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three-six weeks after completing the last cycle of paclitaxel. Doxorubicin: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 cyclophosphamide: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 paclitaxel: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel ( |
| FG001 | Diagnosed With HER2 Positive Breast Cancer | will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year docetaxel: For patients with HER2 positive breast cancer: docetaxel 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles be |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data not collected. PI no longer at this institution
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnosed With HER2 Negative Breast Cancer | Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Pathological Response Rate at the Time of Surgery or at the Time of Biopsy | Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy. | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information. After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
NA Data was not collected
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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 | Diagnosed With HER2 Negative Breast Cancer | Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel. 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica L. Coats | CTCA | 6232073899 | jessica.coats@ctca-hope.com |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D000077560 | Enfuvirtide |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| cyclophosphamide | Drug | doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 |
|
|
| paclitaxel | Drug | For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 |
|
|
| docetaxel | Drug | For patients with HER2 positive breast cancer: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21 |
|
|
| Trastuzumab | Drug | docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21 |
|
|
| Pertuzumab | Drug | docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21 |
|
|
To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer. |
| 4-6 cycles |
| Insulin Abnormalities | Changes in plasma insulin abnormalities after short-term fasting and chemotherapy | 4-6 cycles (up to 12 weeks) |
| Biomarker Changes Before and After Chemotherapy | Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy | 4-6 cycles (up to 12 weeks) |
| Nutritional Assessment Before and After Neoadjuvant Chemotherapy | Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy | 4-6 cycles (up to 12 weeks) |
| Glucose After Fasting and Chemotherapy | To investigate changes in glucose after short-term fasting and chemotherapy | 4-6 cycles (up to 12 weeks) |
| Changes in Insulin-like Growth Factor-1 | To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy | 4-6 cycles (up to 12 weeks) |
| Plasma Blood-based Tumor-related Abnormalities in DNA | To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy | 4-6 cycles (up to 12 weeks) |
| BG001 | Diagnosed With HER2 Positive Breast Cancer | will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Region of Enrollment |
|
| OG001 | Diagnosed With HER2 Positive Breast Cancer | will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year |
|
| Secondary | Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI | The effect of short-term fasting on the toxicity of neoadjuvant chemotherapy in breast cancer patients according to the NCI common toxicity criteria (Version 4.03) | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| Secondary | Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy | To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer. | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles |
|
|
| Secondary | Insulin Abnormalities | Changes in plasma insulin abnormalities after short-term fasting and chemotherapy | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| Secondary | Biomarker Changes Before and After Chemotherapy | Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| Secondary | Nutritional Assessment Before and After Neoadjuvant Chemotherapy | Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| Secondary | Glucose After Fasting and Chemotherapy | To investigate changes in glucose after short-term fasting and chemotherapy | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| Secondary | Changes in Insulin-like Growth Factor-1 | To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| Secondary | Plasma Blood-based Tumor-related Abnormalities in DNA | To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy | Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained. | Posted | 4-6 cycles (up to 12 weeks) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Diagnosed With HER2 Positive Breast Cancer | will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year | 0 | 0 | 0 | 0 |
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| 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 |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |