Clinical Trials /

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

NCT02124902

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
DocetaxelDocefrez®, Taxotere®Baylor: Neoadjuvant docetaxel and carboplatin
CarboplatinParaplatin, Paraplatin-AQBaylor: 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

NameTypeDescriptionInterventions
Washington University: Neoadjuvant docetaxel and carboplatinExperimentalDocetaxel 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.
  • Docetaxel
  • Carboplatin
Baylor: Neoadjuvant docetaxel and carboplatinExperimentalDocetaxel 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.
  • Docetaxel
  • Carboplatin

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:5 months
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:Recruiting
Lead Sponsor:Washington University School of Medicine

Last Updated

November 12, 2019