Cisplatin + RT for Triple Negative Breast Cancer

A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01674842

Enrollment

Registered

2012-08-29

Start date

2012-10-31

Completion date

2021-06-08

Last updated

2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Triple negative, Stage II, Stage III

Brief summary

This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients with ER negative, PR negative and HER2 negative breast cancer who have undergone breast-conserving surgery or mastectomy. Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy

Detailed description

This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity of this combined treatment and establish an MTD.

Interventions

RADIATIONRadiation Therapy

Once daily, Monday - Friday for six weeks

DRUGCisplatin

Intravenously, once weekly for six weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary tumor is triple negative breast cancer * Breast-conserving surgery or mastectomy with surgical excision of all gross disease with negative surgical margins * Pathologic or clinical stage II or III disease * At least 3 week interval from last chemotherapy administration/breast surgery to radiation (no more than 8 weeks)

Exclusion criteria

* Pregnant or breastfeeding * Prior radiation to breast or ipsilateral regional nodes * Ongoing therapy with other investigational agents * Hormonal therapy * Significant co-morbidity * Pathologic complete response following preoperative chemotherapy * Biopsy proven metastatic disease

Design outcomes

Primary

Measure	Time frame	Description
Safety of Cisplatin w/ Radiation	2 years	To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.

Secondary

Measure	Time frame	Description
Local recurrence at 5 years	5 years	To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.
Long term toxicity	2 years	To assess long-term toxicity in participants receiving cisplatin concurrently with radiation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026