Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289353
Recruitment Status : Active, not recruiting
First Posted : February 3, 2011
Last Update Posted : January 26, 2018
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Carboplatin Radiation: 3D-RT or IMRT Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)
Study Start Date : December 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Carboplatin

Arm Intervention/treatment
Experimental: ChemoRT
Concurrent Carboplatin and Radiotherapy
Drug: Carboplatin
IV, weekly for 6 weeks, AUC of 2.0
Other Name: Paraplatin

Radiation: 3D-RT or IMRT

From week 2 to week 4 in the 6-week Carboplatin treatment:

Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion of patients who experience acute toxicities [ Time Frame: baseline, weekly during the 3-week radiation therapy, and 3 weeks after RT ]
  2. 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 ]
  3. recurrence free survival [ Time Frame: every year post treatment up to 10 years ]
    This is an exploratory outcome

  4. overall survival [ Time Frame: every year post treatment up to 10 years ]
    This is an exploratory outcome

  5. Quality of Life [ Time Frame: at baseline, last week of RT, 45-60 days from RT start and 2 yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289353

United States, New York
NYU Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Carmen Perez, MD New York University School of Medicine

Responsible Party: New York University School of Medicine Identifier: NCT01289353     History of Changes
Other Study ID Numbers: 10-01969
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by New York University School of Medicine:
triple negative
breast cancer
adjuvant therapy
radiation therapy
accelerated radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents