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Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity

Sponsor
Washington University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT02124902
Collaborator
National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH), Breast Cancer Research Foundation (Other), Neoimmune Technologies (Other)
123
Enrollment
1
Location
2
Arms
89.8
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery
Actual Study Start Date :
Jul 7, 2014
Actual Primary Completion Date :
Nov 10, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Docetaxel
Other Names:
  • Docefrez®, Taxotere®

    • Drug: Carboplatin
    Other Names:
  • Paraplatin, Paraplatin-AQ

    • Procedure: FDG-PET/MR
    Prior to initialization of Cycle 1 and completion of cycle 1 (preferably on cycle 2 day 1) This is not optional for final 30 participants enrolled on the study
    Experimental: 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.

    Drug: Docetaxel
    Other Names:
  • Docefrez®, Taxotere®

    • Drug: Carboplatin
    Other Names:
  • Paraplatin, Paraplatin-AQ

    • Procedure: FDG-PET/MR
    Prior to initialization of Cycle 1 and completion of cycle 1 (preferably on cycle 2 day 1) This is not optional for final 30 participants enrolled on the study

    Outcome Measures

    Primary Outcome Measures

    1. Pathological Complete Response (pCR) rate [At the time of surgery (surgery will take place 3-5 weeks after completion of treatment and estimated treatment length is 18 weeks)]

      pCR rate will be calculated with 95% CI and will be tested against the reference pCR rate of 35% with standard chemotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • National Institutes of Health (NIH)
    • National Cancer Institute (NCI)
    • Breast Cancer Research Foundation
    • Neoimmune Technologies

    Investigators

    • Principal Investigator: Foluso Ademuyiwa, M.D., MPH, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02124902
    Other Study ID Numbers:
    • 201404107
    • 1U24CA209837-01A1
    First Posted:
    Apr 28, 2014
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Triple Negative Breast Neoplasms
    Breast Neoplasms
    Carboplatin
    Docetaxel

    Study Results

    No Results Posted as of Jan 24, 2022