NCT06607757

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

Recruiting now Phase 2 Last updated 2 April 2025

What this trial tests

Phase 2 trial testing Capivasertib in CCCA Assessed by Ki67 Drop Below <2.7% From Baseline in 120 participants. Currently enrolling.

Timeline

4 December 2024

Primary endpoint
30 June 2026

31 August 2026

Quick facts

Lead sponsor	GBG Forschungs GmbH
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	4 December 2024
Primary completion	30 June 2026
Estimated completion	31 August 2026
Sites	25 locations across Germany

Drugs / interventions tested

• Capivasertib — full drug profile →
• Fulvestrant injection (fulvestrant-injection) — full drug profile →

Conditions studied

• CCCA Assessed by Ki67 Drop Below <2.7% From Baseline — all drugs for CCCA Assessed by Ki67 Drop Below <2.7% From Baseline →

Sponsor

GBG Forschungs GmbH — full company profile →

Who can join

18 and older, female only, with CCCA Assessed by Ki67 Drop Below <2.7% From Baseline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, prospective, open-label, randomized phase II study to evaluate the CCCA assessed by Ki67 drop below \&lt;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 500 mg dose given two weeks after the initial dose) for additional 8 weeks (overall 4 administrations of fulvestrant)

or

\- Fulvestrant (500mg i.m. q28d, with an additional 500 mg dose given two weeks after the core biopsy and the initial dose) for 10 weeks (overall 4 administrations) Treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient.

All patients will undergo core-biopsies, under treatment and after completing study therapy in order to assess Ki67%. Further treatment including surgery, (neo)adjuvant chemotherapy, radiotherapy, and (neo)adjuvant endocrine therapy will be administered at the discretion of the investigator and according to standard of care outside the clinical trial.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Role of PI3K/AKT/mTOR Signaling in Tumor Radioresistance and Advances in Inhibitor Research.
   Zhan J, Jücker M. · · 2025 · cited 6× · PMID 40725100 · DOI 10.3390/ijms26146853