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NCT04973319Possibly a fitNot yet recruiting

HER2-positive breast cancer trial after incomplete neoadjuvant therapy

Breast Cancer

Treatments studied

Part of Cancer, Skin clinical trials.

This Phase 3 study tests giving trastuzumab and pertuzumab as additional (adjuvant) treatment after you had those same medicines before surgery but still had remaining cancer. It may help lower the chance that HER2-positive breast cancer comes back.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
450 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • Be female, age 18 to 75
  • Have an ECOG performance status of 0 to 1 (you’re able to do most normal activities)
  • Have invasive HER2-positive breast cancer confirmed by pathology (HER2 “3+” on the IHC test and HER2 gene amplification/strong signal on the lab test)
  • You had neoadjuvant trastuzumab + pertuzumab, had surgery, and pathology showed leftover invasive cancer in the breast or underarm lymph nodes (not a complete response)
  • You finished trastuzumab + pertuzumab after surgery and the last trastuzumab dose ended within the past 1 year; you must have received at least 24 weeks (8 cycles) total during neoadjuvant and/or adjuvant treatment
  • Your blood counts and organ tests are within required limits (for example, enough white blood cells, platelets, hemoglobin, and acceptable liver function) and you can manage contraception for 8 weeks after the last dose if you can become pregnant

View the official record on ClinicalTrials.gov

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Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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