Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289353
• Other study ID #: 10-01969
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 6, 2009
• Est. completion date: July 8, 2019

Study information

• Verified date: December 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 8, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Carboplatin
IV, weekly for 6 weeks, AUC of 2.0

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

Locations

Country	Name	City	State
United States	NYU Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT		60 days post-RT
Secondary	Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)	Acute Toxicities include all Grade 1 toxicities	6 months to 5 year post-RT
Secondary	Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)		6 months to 5 years post-RT