Cisplatin + RT for Triple Negative Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2021-06-08

Brief Summary

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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

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Detailed Description

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

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cisplatin + Radiation Therapy

Cisplatin concurrently with radiation therapy

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type RADIATION

Once daily, Monday - Friday for six weeks

Cisplatin

Intervention Type DRUG

Intravenously, once weekly for six weeks

Interventions

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Radiation Therapy

Once daily, Monday - Friday for six weeks

Intervention Type RADIATION

Cisplatin

Intravenously, once weekly for six weeks

Intervention Type DRUG

Other Intervention Names

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CDDP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No