Study Summary
This trial is testing paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide to see if it is effective in treating patients with breast cancer.
Eligible Conditions
- Triple Negative Breast Cancer
- Male Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: up to 10 years
Week 28
Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).
Breast
Baseline; at completion of neoadjuvant therapy
Clinical Response Assessed by Tumor Measurement
Radiographic Response Assessed by Tumor Measurement
Week 28
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)
up to 10 years
Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause
Overall Survival
Recurrence-free Survival
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Arm I (paclitaxel, doxorubicin, cyclophosphamide)
1 of 4
Arm II (paclitaxel, ddAC, bevacizumab)
1 of 4
Arm III (paclitaxel, ddAC, carboplatin)
1 of 4
Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)
1 of 4
Active Control
Experimental Treatment
454 Total Participants · 4 Treatment Groups
Primary Treatment: Bevacizumab · No Placebo Group · Phase 2
Arm II (paclitaxel, ddAC, bevacizumab)Experimental Group · 5 Interventions: Bevacizumab, Paclitaxel, Doxorubicin Hydrochloride, Cyclophosphamide, Laboratory Biomarker Analysis · Intervention Types: Biological, Drug, Drug, Drug, Other
Arm III (paclitaxel, ddAC, carboplatin)Experimental Group · 5 Interventions: Paclitaxel, Doxorubicin Hydrochloride, Carboplatin, Cyclophosphamide, Laboratory Biomarker Analysis · Intervention Types: Drug, Drug, Drug, Drug, Other
Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)Experimental Group · 6 Interventions: Bevacizumab, Paclitaxel, Doxorubicin Hydrochloride, Carboplatin, Cyclophosphamide, Laboratory Biomarker Analysis · Intervention Types: Biological, Drug, Drug, Drug, Drug, Other
Arm I (paclitaxel, doxorubicin, cyclophosphamide)ActiveComparator Group · 4 Interventions: Paclitaxel, Doxorubicin Hydrochloride, Cyclophosphamide, Laboratory Biomarker Analysis · Intervention Types: Drug, Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Paclitaxel
FDA approved
Doxorubicin
FDA approved
Carboplatin
FDA approved
Cyclophosphamide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,085 Previous Clinical Trials
41,141,057 Total Patients Enrolled
William M SikovPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor (ER) and progesterone receptor (PgR) negative or staining present in < 10% of invasive cancer cells by immunohistochemistry (IHC).
You have invasive breast cancer, diagnosed by core needle or incisional biopsy (excisional biopsy not permitted).
Patients with multicentric or bilateral disease are eligible if the target lesion meets eligibility criteria.
You have no prior chemotherapy, hormone therapy, or radiation therapy with therapeutic intent for this cancer.
Patients with a history of significant bleeding episodes within 6 months of registration are not eligible.
References
- Sikov, William M., Donald A. Berry, Charles M. Perou, Baljit Singh, Constance T. Cirrincione, Sara M. Tolaney, Charles S. Kuzma, et al.. 2015. “Impact of the Addition of Carboplatin And/or Bevacizumab to Neoadjuvant Once-per-week Paclitaxel Followed by Dose-dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-negative Breast Cancer: CALGB 40603 (alliance)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2014.57.0572.
- Shepherd, Jonathan H., Karla Ballman, Mei-Yin C. Polley, Jordan D. Campbell, Cheng Fan, Sara Selitsky, Aranzazu Fernandez-Martinez, et al.. 2022. “CALGB 40603 (alliance): Long-term Outcomes and Genomic Correlates of Response and Survival After Neoadjuvant Chemotherapy with or Without Carboplatin and Bevacizumab in Triple-negative Breast Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01506.
- 2009. "Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00861705.
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Conditions
Cancer Related
Treatments