A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 18 or older

• Diagnosis of stage I-IIIB breast cancer

• Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)

• Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection

• Candidate for adjuvant chemoradiation as part of standard clinical care

• Planned initiation of radiation within 12 weeks of their final oncologic surgery

• ECOG performance status ≤2

⁃ Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)

⁃ Adequate organ function per the following criteria within 21 days before the start of treatment. If a laboratory value required for study eligibility does not meet the below requirements, the value may be retested.

∙ Absolute neutrophil count ≥1.5 k/uL

‣ Platelets ≥100 k/uL

‣ Hemoglobin ≥ 10 g/dL

‣ Serum Creatinine ≤ 1.5 x ULN

‣ Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed).

‣ AST and ALT ≤ 2.5 x ULN

‣ Alkaline phosphatase ≤ 2.5 x ULN

⁃ For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 6 months after the end of chemoradiation administration or until advised by their medical oncologist

⁃ Agreement to adhere to Lifestyle Considerations throughout study duration

⁃ Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment.

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Song Wood
stw2g@hscmail.mcc.virginia.edu
4342430008
Time Frame
Start Date: 2022-07-11
Estimated Completion Date: 2029-12
Participants
Target number of participants: 45
Treatments
Other: Her2/neu positive and lymph node positive
T-DM1/ trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes
Other: Her2/neu positive and lymph node negative
T-DM1/trastuzumab emtansine infusion along with radiation to the whole breast or chest wall
Other: Her2/neu negative and lymph node positive
oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes
Other: Her2/neu negative and lymph node negative
oral capecitabine twice per day along with radiation to the whole breast or chest wall
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov