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Completed

NCT Number: NCT01674842

Cisplatin + RT for Triple Negative Breast Cancer

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Once daily, Monday - Friday for six weeks

Cisplatin

Drug

Intravenously, once weekly for six weeks

Other names: CDDP

Primary outcomes

  1. Safety of Cisplatin w/ Radiation

    Time frame: 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 outcomes

  1. Local recurrence at 5 years

    Time frame: 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.

  2. Long term toxicity

    Time frame: 2 years

    To assess long-term toxicity in participants receiving cisplatin concurrently with radiation

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2021
First posted
Aug 29, 2012
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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