Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

NCT01289353 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 10-01969
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

triple negative; breast cancer; adjuvant therapy; Carboplatin; chemotherapy; radiation therapy; chemo-radiotherapy; accelerated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT

  60 days post-RT

Secondary Outcomes (2)

• Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)

  6 months to 5 year post-RT

• 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

Study Arms (1)

ChemoRT

EXPERIMENTAL

Concurrent Carboplatin and Radiotherapy

Drug: Carboplatin; Radiation: 3D-RT or IMRT

Interventions

Carboplatin DRUG

IV, weekly for 6 weeks, AUC of 2.0

Also known as: Paraplatin

ChemoRT

3D-RT or IMRT RADIATION

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

ChemoRT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous radiation therapy to the ipsilateral breast
• Active connective tissue disorders, such as lupus or scleroderma
• Pregnant or lactating women

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Carmen Perez, MD, PhD
• Organization: NYU Langone Health - PCC CTO

carmen.perez@nyulangone.org

212-731-5003

Study Officials

• Carmen Perez, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 3, 2011
• Study Start: March 6, 2009
• Primary Completion: July 8, 2019
• Study Completion: July 8, 2019
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

US (1)