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RecruitingPhase 2NCT06607757

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

Phase II Neoadjuvant Study Evaluating Capivasertib Plus Fulvestrant vs Fulvestrant in Patients With Primary High-risk Lobular Breast Cancer- LOBSTER

Sponsor

GBG Forschungs GmbH

Enrollment

120 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

CCCA Assessed by Ki67 Drop Below <2.7% From Baseline

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a targeted therapy drug called capivasertib (which blocks a cancer growth pathway called AKT) to fulvestrant (a hormone-blocking drug) is better than fulvestrant alone for postmenopausal women with a specific type of breast cancer called lobular breast cancer that has not yet been treated. **You may be eligible if...** - You are a postmenopausal woman diagnosed at 18 or older - You have been diagnosed with untreated invasive lobular carcinoma of the breast (a specific breast cancer subtype) - Your cancer is hormone receptor-positive (ER+ and/or PR+) and HER2-negative - You meet criteria for postmenopausal status (age 60+, no periods for 12+ months, or had both ovaries removed) - Your cancer has not yet been treated with systemic therapy **You may NOT be eligible if...** - You have already received treatment for this cancer - You are premenopausal - You have significant heart, liver, or other organ disease that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapivasertib

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DRUGFulvestrant injection

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Locations(25)

Haematologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Germany

Charité

Berlin, Germany

Onkologische Schwerpunktpraxis - Studiengesellschaft Onkologie Bielefeld GbR

Bielefeld, Germany

Hämato-Onkologie im Medicum - Onkologie und Hämatologie

Bremen, Germany

Kliniken der Stadt Köln GmbH - Brustzentrum Köln-Holweide

Cologne, Germany

Carl-Thiem-Klinikum gGmbH - Frauenklinik

Cottbus, Germany

Kath. St. Paulus GmbH - Klinische Forschung

Dortmund, Germany

Universitätsklinikum Essen - Klinik für Frauenheilkunde und Geburtshilfe

Essen, Germany

Klinikum Frankfurt Höchst GmbH - Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, Germany

Praxis für Interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Germany

Mammazentrum Hamburg - am Krankenhaus Jerusalem

Hamburg, Germany

Universitätsklinikum des Saarlandes - Frauenklinik

Homburg, Germany

Klinikum Kassel GmbH - Frauenklinik

Kassel, Germany

St. Elisabethen-Krankenhaus gGmbH - Senologie / Brustzentrum

Leipzig, Germany

Medizinisches Versorgungszentrum MediaVita GmbH Muenster

Münster, Germany

Klinikum Oldenburg AöR - Universitätsklinik für Innere Medizin - Onkologie

Oldenburg, Germany

MVZ für Hämatolgie und Onkologie Ravensburg GmbH - Studienzentrum

Ravensburg, Germany

Klinikum Südstadt - Universitätsfrauenklinik

Rostock, Germany

Leopoldina-Krankenhaus der Stadt Schweinfurt - Frauenklinik

Schweinfurt, Germany

Johanniter-Krankenhaus Genthin-Stendal - Klinik für Frauenheilkunde und Geburtshilfe

Stendal, Germany

Kreiskrankenhaus Torgau - Gynäkologie

Torgau, Germany

Praxisnetzwerk Haematologie und internistische Onkologie Ueberoertliche Berufsausuebungsgemeinschaft - Hämatologie und Onkologie

Troisdorf, Germany

Marienhospital Witten - Brustzentrum

Witten, Germany

Klinikum Worms gGmbH - Frauenklinik

Worms, Germany

Helios Klinikum Wuppertal GmbH - Landesfrauenklinik

Wuppertal, Germany

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NCT06607757