A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

About this Study

This purpose of the study is to see well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk HER2 positive breast cancer.

Sponsor Protocol ID:A011801
IRB Number:2020-0244
Actively Enrolling
Interventional
Phase 3
June 30, 2022
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
  • HER2 positive
  • Patient with clinical stage T1-4, N0-3 and residual invasive disease post surgery can enroll
  • Patient with residual HR-negative, HER2 positive disease in breast and/or lymph nodes   per surgical pathology report can enroll
  • Must have received neoadjuvant chemotherapy with one of the following regimens:  docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)
  • May have received one cycle of T-DM1 in the adjuvant setting
  • All systemic chemotherapy should have been completed preoperatively unless in EA1181
  • Toxicities related to prior systemic treatment should have been resolved or be at baseline, expect for alopecia (hair loss) and peripheral neuropathy
  • Must have ejection fraction of greater than or equal to 50%

Exclusion Criteria
  • No prior adjuvant treatment with anti-cancer investigational drug within 28 days prior to registration
  • Must not be pregnant or nursing
  • Must not have known active and/or untreated hepatitis B or hepatitis C or chronic liver disease
  • Must not have stage IV (metastatic) breast cancer
  • History of any   prior invasive breast cancer within 3 year s of registration
  • Evidence of recurrent disease following preoperative therapy of surgery

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Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
Contact Information
Contact Name: Jessica Solise
Phone Number: 601-984-1963
Email: jsolise@umc.edu
Principal Investigator:Tang, Shou-Ching, M.D.Ph.D., M.D., Ph.D.
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