Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer

NCT ID: NCT02547987

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2025-09-30

Brief Summary

The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.

Detailed Description

PRIMARY OBJECTIVE:

To determine whether neoadjuvant docetaxel and carboplatin will increase the pCR rate in TNBC compared to historical controls. Pathologic complete response (pCR) will be defined as no residual invasive breast cancer in the breast and ipsilateral axillary lymph node (ypT0-is ypN0).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel/Carboplatin

Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6

Interventions

Docetaxel

Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6

Intervention Type: DRUG

Carboplatin

Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6

Intervention Type: DRUG

Other Intervention Names

Taxotere; Paraplatin

Eligibility Criteria

Inclusion Criteria

• All patients must be 18 years of age or older.
• All patients must be diagnosed with invasive breast cancer.
• Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than 5.
• Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic exam. Patients who have multicentric breast cancer are eligible if each lesion is estrogen receptor negative and HER2-negative. In that case, one lesion needs to be identified as the index lesion to be followed for clinical response. The index lesion must also be the lesion from which core biopsies are obtained.
• Patients with inflammatory breast cancer are eligible if they meet both of the following criteria:

1. Patient has an underlying, clinically palpable breast mass of at least 2cm, AND

2. a corresponding lesion is visualized on mammogram or ultrasound

• Normal bone marrow and organ function as defined below:

• Leukocytes > 3,000/mcL
• Absolute neutrophil count > 1,200/mcl
• Platelets > 100,000/mcl
• Serum bilirubin ≤ institutional 1.5 times upper limit of normal (ULN)
• Aspartate aminotransferase/alanine aminotransferase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 ULN
• Women of childbearing potential (defined as women under the age of 55 with intact ovaries and uterus) must agree to use adequate contraception prior to study entry and for the duration of study participation. They must also have a negative urine pregnancy test within 7 days of starting treatment.
• Ability to understand and willingness to sign an IRB approved written informed consent document and follow study procedures including willingness to undergo study biopsies.

Exclusion Criteria

• Any prior systemic therapy for breast cancer within 5 years.
• 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 known bilateral invasive breast cancer. Patients with contralateral in situ breast carcinoma are eligible.
• Inflammatory breast cancer.
• Patients with confirmed stage IV disease.
• Currently receiving any other investigational agents.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin.
• Known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• 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.
• If the patient is otherwise not deemed a good study candidate by sole discretion of the principal investigator.
• Patient is pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mothaffar Rimawi

OTHER

Sponsor Role: lead

Responsible Party

Mothaffar Rimawi

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mothaffar Rimawi, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

TriHealth Hatton Research

Cincinnati, Ohio, United States

Lester & Sue Smith Breast Center at Baylor College of Medicine

Houston, Texas, United States

Harris Health System Smith Clinic

Houston, Texas, United States

Countries

United States

References

Ademuyiwa FO, Chen I, Luo J, Rimawi MF, Hagemann IS, Fisk B, Jeffers G, Skidmore ZL, Basu A, Richters M, Ma CX, Weilbaecher K, Davis J, Suresh R, Peterson LL, Bose R, Bagegni N, Rigden CE, Frith A, Rearden TP, Hernandez-Aya LF, Roshal A, Clifton K, Opyrchal M, Akintola-Ogunremi O, Lee BH, Ferrando-Martinez S, Church SE, Anurag M, Ellis MJ, Gao F, Gillanders W, Griffith OL, Griffith M. Immunogenomic profiling and pathological response results from a clinical trial of docetaxel and carboplatin in triple-negative breast cancer. Breast Cancer Res Treat. 2021 Aug;189(1):187-202. doi: 10.1007/s10549-021-06307-3. Epub 2021 Jun 26.

Reference Type: DERIVED

PMID: 34173924 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H- 36960 CADENCE

Identifier Type: -

Identifier Source: org_study_id