Clinical Trials /

Cisplatin + RT for Triple Negative Breast Cancer

NCT01674842

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Cisplatin</span> + RT for Triple Negative <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Cisplatin + RT for Triple Negative Breast Cancer
  • Official Title: A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT01674842

    ORG ID: 12-283

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin CDDP Cisplatin + Radiation Therapy

    Trial Purpose

    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.

    Trial Arms

    Name Type Description Interventions
    Cisplatin + Radiation Therapy Experimental Cisplatin concurrently with radiation therapy Cisplatin

    Eligibility Criteria

    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

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety of Cisplatin w/ Radiation

    Secondary Outcome Measures

    Local recurrence at 5 years

    Long term toxicity

    Trial Keywords

    Triple negative

    Stage II

    Stage III