Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

This study is currently recruiting participants.
Verified January 2014 by New York University School of Medicine
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01289353
First received: January 31, 2011
Last updated: January 24, 2014
Last verified: January 2014

January 31, 2011
January 24, 2014
December 2010
April 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01289353 on ClinicalTrials.gov Archive Site
  • Proportion of patients who experience acute toxicities [ Time Frame: baseline, weekly during the 3-week radiation therapy, and 3 weeks after RT ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • recurrence free survival [ Time Frame: every year post treatment up to 10 years ] [ Designated as safety issue: No ]
    This is an exploratory outcome
  • overall survival [ Time Frame: every year post treatment up to 10 years ] [ Designated as safety issue: No ]
    This is an exploratory outcome
  • Quality of Life [ Time Frame: at baseline, last week of RT, 45-60 days from RT start and 2 yrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer
Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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

Experimental: ChemoRT
Concurrent Carboplatin and Radiotherapy
Interventions:
  • Drug: Carboplatin
  • Radiation: 3D-RT or IMRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2021
April 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Silvia Formenti, MD 212-731-5039 silvia.formenti@nyumc.org
Contact: Ravindran Kathirithamby 212-731-5335 Ravindran.Kathirithamby@nyumc.org
United States
 
NCT01289353
NYU 10-01969
Yes
Silvia Formenti, NYU Cancer Institute
New York University School of Medicine
Not Provided
Principal Investigator: Silvia Formenti, MD New York University School of Medicine
New York University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP