Clinical Trials /

Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

NCT01289353

Description:

The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
  • Official Title: Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)

Clinical Trial IDs

  • ORG STUDY ID: 10-01969
  • NCT ID: NCT01289353

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
CarboplatinParaplatinChemoRT

Purpose

The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.

Detailed Description

      Preliminary experience in the neo-adjuvant setting of Locally Advanced Breast Cancer (LABC)
      has recently demonstrated that hormone receptors negative patients have approximately 50%
      chance to achieve a pathological response after concurrent chemo-radiation. In a
      multi-institutional collaboration of 105 patients it was found that triple negative (TN)
      tumor carriers achieved pathological response in 54% of the cases and that the response
      reflected on 5-year disease free survival and overall survival. Our group has speculated that
      these effects on the risk of distant recurrence could depend on the recovery of antitumor
      immunity among the patients achieving pathological response, after tumor cell death induced
      by concurrent chemo-radiation.

      The investigators are proposing a novel study that translates these findings to the adjuvant
      setting of TN tumors. TN breast cancer is a more aggressive form of the disease often
      coinciding with basal-like tumors. BRCA mutated-cancer is more frequently TN.

      The current protocol converges the experience NYU has developed in accelerated prone breast
      radiotherapy with encouraging finding from the use of concurrent chemoradiation in LABC.

      The investigators will study the feasibility of combining weekly carboplatin with concurrent
      3-weeks prone breast radiotherapy in the adjuvant setting of 35 women with TN tumors, after
      segmental mastectomy and nodal assessment. Primary endpoint of the study is acute toxicity of
      the combined regimen, with a target of < 25% of grade II-III dermatitis.
    

Trial Arms

NameTypeDescriptionInterventions
ChemoRTExperimentalConcurrent Carboplatin and Radiotherapy
  • Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Age older than 18

          -  Pre- or post-menopausal women with Stage I and II breast cancer, triple negative
             tumors

          -  Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm

          -  Status post segmental mastectomy, after sentinel node biopsy and/or axillary node
             dissection (Tumors < 5 mm in size do not require nodal assessment) or after mastectomy

          -  No previous chemotherapy

          -  Patient needs to be able to understand and demonstrate willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Previous radiation therapy to the ipsilateral breast

          -  Active connective tissue disorders, such as lupus or scleroderma

          -  Pregnant or lactating women
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:The proportion of patients who experience grade II-III dermatitis within 60 days post radiation treatment
Time Frame:up to 60 days after the end of radiation treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Proportion of patients who experience acute toxicities
Time Frame:baseline, weekly during the 3-week radiation therapy, and 3 weeks after RT
Safety Issue:
Description:
Measure:proportion of patients who experience grade 2 or higher late toxicities after 60 days post radiation treatment
Time Frame:60 days to 5 years post radiation treatment
Safety Issue:
Description:
Measure:recurrence free survival
Time Frame:every year post treatment up to 10 years
Safety Issue:
Description:This is an exploratory outcome
Measure:overall survival
Time Frame:every year post treatment up to 10 years
Safety Issue:
Description:This is an exploratory outcome
Measure:Quality of Life
Time Frame:at baseline, last week of RT, 45-60 days from RT start and 2 yrs
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:New York University School of Medicine

Trial Keywords

  • triple negative
  • breast cancer
  • adjuvant therapy
  • Carboplatin
  • chemotherapy
  • radiation therapy
  • chemo-radiotherapy
  • accelerated radiotherapy

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