A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel
- Conditions
- Triple Negative Breast Neoplasms
- Sponsor
- Washington University School of Medicine
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Pathological Complete Response (pCR) Rate
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Newly diagnosed AJCC7 clinical stage II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant chemotherapy as the treatment goal.
- •Patients with PR+ tumors are allowed.
- •HER2 negative by FISH or IHC staining 0 or 1+.
- •ER less than Allred score of 3 or less than 1% positive staining cells in the invasive component of the tumor
- •Tumor size at least 2cm in one dimension by clinical or radiographic exam (WHO criteria). Patients with palpable lymph nodes may be enrolled regardless of tumor size.
- •At least 18 years of age.
- •ECOG performance status ≤ 2
- •Normal bone marrow and organ function as defined below:
- •Leukocytes ≥ 3,000/mcL
- •Absolute neutrophil count ≥ 1,500/mcl
Exclusion Criteria
- •Prior systemic therapy for the indexed breast cancer.
- •A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
- •Patients with bilateral or inflammatory breast cancer.
- •Currently receiving any other investigational agents.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant and/or breastfeeding. Patient must have a negative serum pregnancy test within 7 days of study entry if premenopausal.
- •Known HIV-positivity.
- •Sentinel lymph node biopsy
- •Renal insufficiency (glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2) measured within the past 60 days which precludes safe administration of the contrast agent
Arms & Interventions
Washington University: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
Intervention: Docetaxel
Washington University: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
Intervention: Carboplatin
Washington University: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
Intervention: FDG-PET/MR
Baylor: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Intervention: Docetaxel
Baylor: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Intervention: Carboplatin
Baylor: Neoadjuvant docetaxel and carboplatin
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Intervention: FDG-PET/MR
Outcomes
Primary Outcomes
Pathological Complete Response (pCR) Rate
Time Frame: At the time of surgery (surgery will take place 3-5 weeks after completion of treatment and estimated treatment length is 18 weeks)
-A patient is considered to not to have a pCR if any of the following are true: * There is histologic evidence of invasive tumor cells in the surgical breast specimen or the axillary lymph nodes. * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity, or radiographic evidence of progression and then goes straight to surgery where there is histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity or radiographic evidence of progression and then receives alternative treatment. * The patient discontinues study treatment, refuses surgery, or is unable to undergo surgery due to a co-morbid condition. Thus, any patient who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pCR.