Cisplatin for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerCyclophosphamide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is a Phase II study of cisplatin in patients with BRCA-mutated breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 5 years

2 years
Number of Grade 3 and Grade 4 Adverse Events
Rate of Residual Cancer Burden (RCB) 0/1
3 years
Clinical Response Rate
Rate of Miller Payne 4 and 5
Rate of Pathologic Complete Response (pCR)
5 years
Analysis of Pre-chemotherapy Biopsies
Rate of Recurrence Free Survival (RFS) After Cisplatin or AC
Rate of Recurrence Free Survival (RFS) With Pathologic Complete Response (pCR) vs. With no pCR

Trial Safety

Trial Design

2 Treatment Groups

Cisplatin
1 of 2
Doxorubicin-Cyclophosphamide
1 of 2

Active Control

118 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2

Cisplatin
Drug
ActiveComparator Group · 1 Intervention: Cisplatin · Intervention Types: Drug
Doxorubicin-CyclophosphamideActiveComparator Group · 2 Interventions: Cyclophosphamide, Doxorubicin · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
777 Previous Clinical Trials
845,636 Total Patients Enrolled
43 Trials studying Breast Cancer
5,303 Patients Enrolled for Breast Cancer
Nadine Tung, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
2 Previous Clinical Trials
414 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient has Stage Clinical T1 >/= 1.0 cm, T2 or T3, N0-3, M0.
The patient is likely to live for more than six months.
Patients who are ER and PgR positive by immunohistochemistry must have their status known