1280.4: A Phase Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancer

Completed

Conditions: 10006291
breast cancer
mammacarcinoma

Registration Number: NL-OMON40248

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

- Histologically-confirmed locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
- Tumors are positive for estrogen-receptor (ER) and/or progesterone receptor (PgR). Tumors must be negative for HER2 per local lab testing.
- Postmenopausal women
- Objective evidence of recurrence or progression on or after the last systemic therapy prior to the study entry
- Disease refractory to non-steroidal aromatase inhibitors (letrozole and/or anastrozole)
- ECOG<<=2
- Patients must have a measurable lesion according to RECIST version 1.1 or bone
lesion only: lytic or mixed (lytic + sclerotic) in the absence of measurable lesions

Exclusion Criteria

-Previous treatment with agents targeting on IGF pathway, PI3K signaling pathway, protein kinase B (AKT), or mTOR pathways (sirolimus, temsirolimus, etc.)
-Prior treatment with exemestane
-History of another primary malignancy within 5 years, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the phase 2 part of the study is progression free<br /><br>survival (PFS), which is defined as the duration of time from the date of C1V1<br /><br>until the date of the first objective tumor progression or death due to any<br /><br>cause.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Time to progression (TTP), defined as the duration of time from the date of<br /><br>C1V1 until the date of the first objective tumor progression<br /><br>2. Objective response (OR), defined as complete response (CR) or partial<br /><br>response (PR)<br /><br>3. Time to objective response<br /><br>4. Duration of objective response<br /><br>5. Clinical benefit (CB), defined as best overall response of complete response<br /><br>(CR) or partial response (PR), or stable disease (SD) 6 months, or<br /><br>Non-CR/Non-PD for 6 months<br /><br>6. Duration of clinical benefit</p><br>