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Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen

NCT03304756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-10-25

No results posted yet for this study

Summary

This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days was further provided for 4 cycles. Primary outcome was pathological complete response in the breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and overall survival.

Conditions

  • Triple Negative Breast Cancer Patients

Interventions

DRUG

CAP

cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles

Sponsors & Collaborators

Principal Investigators

  • José Bines, Doctorate · Instituto Nacional de Cancer

  • Otto Metzger, Oncologist · Medical oncologist in Boston, and affiliated with Dana-Farber Cancer Institute

  • José Bines, Doctorate · Instituto Nacional de Cancer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-15
Primary Completion
2012-04-15
Completion
2014-12-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304756 on ClinicalTrials.gov