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

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ClinicalTrials.gov Identifier: NCT02124902
Recruitment Status : Recruiting
First Posted : April 28, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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
Triple Negative Breast Neoplasms Drug: Docetaxel Drug: Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
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 : July 7, 2014
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
Drug: Docetaxel
Other Name: Docefrez®, Taxotere®

Drug: Carboplatin
Other Name: Paraplatin, Paraplatin-AQ

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 Name: Docefrez®, Taxotere®

Drug: Carboplatin
Other Name: Paraplatin, Paraplatin-AQ




Primary Outcome Measures :
  1. Pathological Complete Response (pCR) rate [ Time Frame: 5 months ]
    pCR rate will be calculated with 95% CI and will be tested against the reference pCR rate of 35% with standard chemotherapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed 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).
  • If consenting to participate in the optional PET/MR imaging sub-study, the patient must be 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
  • For patients who agree to participate in PET/MR imaging:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124902


Contacts
Contact: Foluso Ademuyiwa, M.D., MPH 314-362-7201 bisiademuyiwa@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Foluso Ademuyiwa, M.D., MPH    314-362-7201    bisiademuyiwa@wustl.edu   
Sub-Investigator: Cynthia Ma, M.D., Ph.D.         
Sub-Investigator: Ron Bose, M.D., Ph.D.         
Sub-Investigator: Michael Naughton, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Souzan Sanati, M.D.         
Sub-Investigator: Julie Margenthaler, M.D.         
Sub-Investigator: Rebecca Aft, M.D., Ph.D.         
Sub-Investigator: Amy Cyr, M.D.         
Sub-Investigator: Timothy Eberlein, M.D.         
Sub-Investigator: William Gillanders, M.D.         
Sub-Investigator: Mathew Cherian, M.D.         
Sub-Investigator: Ashley Frith, M.D.         
Sub-Investigator: Leonel Hernandez Aya, M.D.         
Sub-Investigator: Peter Oppelt, M.D.         
Sub-Investigator: Caron Rigden, M.D.         
Sub-Investigator: Haeseong Park, M.D.         
Sub-Investigator: Katherine Weilbaecher, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Foluso Ademuyiwa, M.D., MPH Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02124902     History of Changes
Other Study ID Numbers: 201404107
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action