Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
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
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: December 2010
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289353

Contacts
Contact: Silvia Formenti, MD 212-731-5039 silvia.formenti@nyumc.org
Contact: Ravindran Kathirithamby 212-731-5335 Ravindran.Kathirithamby@nyumc.org

Locations
United States, New York
NYU Cancer Center Recruiting
New York, New York, United States, 10016
Principal Investigator: Yelena Novik, MD         
Principal Investigator: Silvia Formenti, MD         
Sub-Investigator: James Speyer, MD         
Sub-Investigator: Sylvia Adams, MD         
Sub-Investigator: Stella Lymberis, MD         
Sub-Investigator: Nelly Huppert, MD         
Sub-Investigator: Brian Yeh, M.D.         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Silvia Formenti, MD New York University School of Medicine
  More Information

No publications provided

Responsible Party: Silvia Formenti, NYU Cancer Institute
ClinicalTrials.gov Identifier: NCT01289353     History of Changes
Other Study ID Numbers: NYU 10-01969
Study First Received: January 31, 2011
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014