Description:
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.
Title
- Brief Title: Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
- Official Title: A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
Clinical Trial IDs
- ORG STUDY ID:
201404107
- SECONDARY ID:
1U24CA209837-01A1
- NCT ID:
NCT02124902
Conditions
- Triple Negative Breast Neoplasms
Interventions
Drug | Synonyms | Arms |
---|
Docetaxel | Docefrez®, Taxotere® | Baylor: Neoadjuvant docetaxel and carboplatin |
Carboplatin | Paraplatin, Paraplatin-AQ | Baylor: Neoadjuvant docetaxel and carboplatin |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Washington University: Neoadjuvant docetaxel and carboplatin | Experimental | 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. | |
Baylor: Neoadjuvant docetaxel and carboplatin | Experimental | 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. | |
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
- Platelets ≥ 100,000/mcl
- Serum bilirubin within (or under ) normal limits (OR total bilirubin ≤ 3.0 x IULN
with direct bilirubin within normal range in patients with well documented
Gilbert Syndrome)
- AST(SGOT)/ALT(SGPT) within (or under ) normal limits
- Creatinine clearance ≥ 60 mL/min/1.73 m2
- Patients may be pre- or post-menopausal. Women of childbearing potential must agree to
use adequate contraception (hormonal or barrier method of birth control, abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she must
inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
- Able to tolerate PET/MRI with intravenous contrast administration and must complete
the applicable MRI screening evaluation form
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
- On dialysis
- Prior allergic reaction to gadolinium-based MR contrast agents
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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) |
Safety Issue: | |
Description: | pCR rate will be calculated with 95% CI and will be tested against the reference pCR rate of 35% with standard chemotherapy |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Washington University School of Medicine |
Last Updated
July 23, 2021