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Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)

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.

Inclusion Criteria:

- Age older than 18

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients who experience grade II-III dermatitis within 60 days post radiation treatment

Outcome Time Frame:

up to 60 days after the end of radiation treatment

Safety Issue:


Principal Investigator

Silvia Formenti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Institutional Review Board

Study ID:

NYU 10-01969



Start Date:

December 2010

Completion Date:

December 2021

Related Keywords:

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



NYU Cancer Center New York, New York  10016