Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer

This is a multicenter, prospective, open-label, randomized phase II study to evaluate the CCCA assessed by Ki67 drop below \<2.7% from baseline to week 2 (window of opportunity) and to week 10 with capivasertib plus fulvestrant compared with fulvestrant alone as neoadjuvant treatment for primary high-risk lobular breast cancer patients. 120 patients will be randomized to receive: \- Capivasertib (400 mg po twice daily d1-4 followed by 3 days off) for 2 weeks followed by capivasertib (400 mg po twice daily d1-4 followed by 3 days off) and fulvestrant (500 mg i.m. q28d, with an additional 5

Trial Details

NCT ID
NCT06607757
Phase
PHASE2
Sponsor
GBG Forschungs GmbH
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • Capivasertib
  • Fulvestrant injection
Locations (sample)
  • Augsburg, Germany|48.37154,10.89851
  • Berlin, Germany|52.52437,13.41053
  • Bielefeld, Germany|52.03333,8.53333
  • Bremen, Germany|53.07582,8.80717
  • Cologne, Germany|50.93333,6.95

Key Eligibility Criteria

  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and foll…
  • Postmenopausal women with age at diagnosis ≥ 18 years.
  • Postmenopausal status is defined as:
  • Age ≥60 years

For full eligibility, visit ClinicalTrials.gov.

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