NCT02547987

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 13, 2019

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

February 1, 2025

Enrollment Period

3.6 years

First QC Date

September 10, 2015

Results QC Date

October 24, 2019

Last Update Submit

February 25, 2025

Conditions

Breast Cancer

Keywords

breast cancertriple negativeTNBCtriple negative breast cancer

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response

    This is the complete disappearance of invasive cancer in the breast at the time of surgery

    At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)

Study Arms (1)

Docetaxel/Carboplatin

EXPERIMENTAL

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

Drug: DocetaxelDrug: Carboplatin

Interventions

DocetaxelDRUG

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

Also known as: Taxotere
Docetaxel/Carboplatin
CarboplatinDRUG

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

Also known as: Paraplatin
Docetaxel/Carboplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Patient has an underlying, clinically palpable breast mass of at least 2cm, AND
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

TriHealth Hatton Research

Cincinnati, Ohio, 45242, United States

Location

Lester & Sue Smith Breast Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Harris Health System Smith Clinic

Houston, Texas, 77054, United States

Location

Related Publications (1)

  • 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.

    PMID: 34173924DERIVED

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

DocetaxelCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Results Point of Contact

Title
Mothaffar Rimawi, M.D.
Organization
Baylor College of Medicine
rimawi@bcm.edu
713-798-1311

Study Officials

  • Mothaffar Rimawi, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 14, 2015

Study Start

November 1, 2015

Primary Completion

June 25, 2019

Study Completion

September 1, 2025

Last Updated

March 12, 2025

Results First Posted

November 13, 2019

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)