BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Everolimus; Drug: Exemestane; Drug: BI 836845

• Registration Number: NCT02123823
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Study Start: 2014-05-15
• Primary Completion: 2016-11-25
• Study Completion: 2021-12-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PhI - BI836845 + Everolimus + Exemestane	BI 836845	Phase I - Dose escalation (24-48 patients) BI 836845 low or high dose, Everolimus 5mg, 7,5mg or 10 mg and Exemestane 25mg
BI836845 + Everolimus + Exemestane	BI 836845	Phase II - BI 836845 recommended dose will be administered intravenously once every week, in addition to daily everolimus (oral administration at recommended dose) + daily exemestane 25 mg orally
Everolimus 10mg + Exemestane 25mg	Everolimus	Phase II - Daily everolimus oral administration 10mg + daily exemestane 25 mg orally
Everolimus 10mg + Exemestane 25mg	Exemestane	Phase II - Daily everolimus oral administration 10mg + daily exemestane 25 mg orally
BI836845 + Everolimus + Exemestane	Everolimus	Phase II - BI 836845 recommended dose will be administered intravenously once every week, in addition to daily everolimus (oral administration at recommended dose) + daily exemestane 25 mg orally
BI836845 + Everolimus + Exemestane	Exemestane	Phase II - BI 836845 recommended dose will be administered intravenously once every week, in addition to daily everolimus (oral administration at recommended dose) + daily exemestane 25 mg orally
PhI - BI836845 + Everolimus + Exemestane	Everolimus	Phase I - Dose escalation (24-48 patients) BI 836845 low or high dose, Everolimus 5mg, 7,5mg or 10 mg and Exemestane 25mg
PhI - BI836845 + Everolimus + Exemestane	Exemestane	Phase I - Dose escalation (24-48 patients) BI 836845 low or high dose, Everolimus 5mg, 7,5mg or 10 mg and Exemestane 25mg

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) - phase I part	up to 15 months
Occurrence of Dose Limiting Toxicity (DLT) - phase I part	up to 28 days
Progression-free survival (PFS)	up to 11 months

Secondary Outcome Measures

Name	Time	Method
Objective response (OR), defined as complete response (CR) or partial response (PR) (CR + PR)	up to 11 months
Time to progression (TTP), defined as the duration of time from the date of randomization until the date of the first objective tumor progression	up to 11 months
Disease control (DC), defined as best overall response of complete response (CR) or partial response (PR), or stable disease (SD) >=24 weeks, or Non-CR/Non-PD for >=24 weeks (CR + PR + SD24w + Non-CR/Non-PD24w)	up to 11 months
Time to objective response, defined as the time from randomisation until first documented CR or PR	up to 11 months
Duration of objective response, defined as the time from first documented CR or PR until the earliest of disease progression or death among patients with OR	up to 11 months
Duration of disease control, defined as the time from randomisation until the earliest of disease progression or death, among patients with disease control	up to 11 months

Trial Locations

Locations (38)

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

LKH-Univ. Hospital Graz; 🇦🇹 Graz, Austria

Wilhelminenspital; 🇦🇹 Wien, Austria

Liège - HOSP St-Joseph; 🇧🇪 Liège, Belgium

INS Paoli-Calmettes; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

Freeman Hospital; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Ctr Cario; 🇫🇷 Plerin Sur Mer, France

INS Curie; 🇫🇷 Paris, France

CTR Catherine de Sienne; 🇫🇷 Nantes, France

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Centrummottagningen; 🇸🇪 Stockholm, Sweden

Ninewells Hospital & Medical School; 🇬🇧 Dundee, United Kingdom

HOP Européen G. Pompidou; 🇫🇷 Paris, France

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

HOP Jean Minjoz; 🇫🇷 Besançon, France

St Vincent's University Hospital; 🇮🇪 Dublin 4, Ireland

Maastricht University; 🇳🇱 Maastricht, Netherlands

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

MD Anderson Cancer Center Madrid; 🇪🇸 Madrid, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Brussels - UNIV Saint-Luc; 🇧🇪 Bruxelles, Belgium

Edegem - UNIV UZ Antwerpen; 🇧🇪 Edegem, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

CHU UCL Namur - Site De Sainte-Elisabeth; 🇧🇪 Namur, Belgium

Brussels - UNIV UZ Brussel; 🇧🇪 Brussel, Belgium

Charleroi - HOSP Grand Hôpital de Charleroi; 🇧🇪 Charleroi, Belgium