BI836845 in women with Breast Cancer.
Research type
Research Study
Full title
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.
IRAS ID
147215
Contact name
Ruth Plummer
Contact email
Eudract number
2013-001110-15
Research summary
TResearch Summary
his is 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. The study is in two parts: A Phase I, single arm, dose escalation with BI 836845 + everolimus + exemestane and a Phase II, consisting of two arms, randomized, parallel design; arm 1: everolimus + exemestane ; arm 2: BI 836845 + everolimus + exemestane. Between 171 and 198 patients are planned to be recruited globally.Summary of Results
: Study title:
A study to find the optimal dose of xentuzumab taken together with exemestane and everolimus in women with (HR+/HER2-) breast cancer that is advanced or has spread This is a summary of results from one clinical study.
We thank all study participants. You helped us to answer important questions about xentuzumab and the treatment of breast cancer.What was this study about?
This study was about testing xentuzumab taken with exemestane and everolimus in women with a certain type of advanced breast cancer. Exemestane with everolimus is a standard combination chemotherapy treatment for advanced cancer. Treatment with xentuzumab was stopped early in this study. This was because the addition of xentuzumab to the combination chemotherapy treatment did not help more in treating advanced breast cancer than the combination chemotherapy treatment alone.
This study had 2 parts, and each part is described separately in the following sections.
The purpose of part 1 was to find the highest dose of xentuzumab that participants could tolerate when taken with exemestane and everolimus. We also wanted to determine the dose of xentuzumab that participants in part 2 would take.
The purpose of part 2 of this study was to compare 2 different treatment combinations for advanced breast cancer. We wanted to find out whether xentuzumab added to the combination chemotherapy treatment exemestane and everolimus is more effective than exemestane and everolimus alone for treating advanced breast cancer.Who took part in this study?
In this study, women with a certain type of breast cancer (HR+/HER2-) that had advanced or spread could take part.
Part 1:
24 women participated in part 1 of this study. The average age was 65 years. The youngest participant was 49 years old and the oldest participant was 80 years old. Part 1 of this study was done in Belgium, France, The Netherlands, Spain, and Sweden. None of the participants in part 1 of this study took part in part 2.
Part 2:
139 women participated in part 2 of this study. The average age was 60 years. The youngest woman was 41 years old and the oldest woman was 86 years old. The study was stopped before part 2 was completed.
The following listing shows the numbers of participants in part 2 of the study in different regions.
Europe (Austria, Belgium, France, Ireland, Netherlands, Spain, Sweden, United Kingdom): 115 participants Asia (South Korea, Taiwan): 24 participantsHow was this study done?
Xentuzumab is given as an infusion into a vein. Exemestane and everolimus are tablets that patients swallow.
Part 1:
Before starting xentuzumab, all participants took exemestane (25 mg) and everolimus (10 mg) daily for 7 days.
The first 3 participants received 750 mg xentuzumab weekly. Participants who started the study later received 1000 mg xentuzumab weekly. All participants also continued to take exemestane and everolimus. The participants and doctors knew which treatment the participants were getting.
We wanted to find the highest dose of xentuzumab participants could tolerate when combined with exemestane and everolimus. To find out, we looked at the number of participants with certain severe health problems. These were severe health problems that happened within 4 weeks after the first xentuzumab treatment.
Part 2:
Participants in part 2 were different participants than those in part 1. Participants were divided into 2 groups. Every participant had an equal chance of being in each group. One group took xentuzumab (1000 mg weekly) in combination with exemestane (25 mg daily) and everolimus (10 mg daily). The second group took exemestane (25 mg daily) and everolimus (10 mg daily). Both groups took the study medicines until their cancer grew again or they could no longer tolerate the medicine. The participants and doctors knew which treatment the participants were getting.
Treatment with xentuzumab was stopped early in the study. Treatment with exemestane and everolimus was continued. We measured the time from starting the study medicines until the cancer grew again or the patient died. This is called ‘progression-free survival’.
During both parts of the study, participants visited the doctors regularly. During these visits, the doctors collected information about the participant’s health.What were the results of this study?
Part 1:
We found that the highest dose of xentuzumab the participants could tolerate when taken with exemestane and everolimus was 1000 mg per week. No participant had a severe health problem with this dose.
Part 2:
We found that progression-free survival was similar for the participants in the 2 groups. In the xentuzumab with exemestane and everolimus group, progression-free survival was around 7 months. In the exemestane and everolimus alone group, progression-free survival was around 6 months.Did participants have any unwanted effects?
Yes, participants in both parts of this study had unwanted effects. Unwanted effects are health problems that the doctors think were caused by the study medicines.
Part 1:
All 24 participants in this part of the study had unwanted effects.
The listing below shows the most common unwanted effects in part 1 of this study. The listing also shows how many participants had each of these unwanted effects.
Decreased appetite
• Xentuzumab 750 mg + exemestane and everolimus (3 participants): 1 participant (33%)
• Xentuzumab 1000 mg + exemestane and everolimus (21 participants): 12 participants (57%)Low number of red blood cells (anaemia)
• Xentuzumab 750 mg + exemestane and everolimus (3 participants): 2 participants (67%)
• Xentuzumab 1000 mg + exemestane and everolimus (21 participants): 11 participants (52%)Inflammation of the mucous linings (mucosal inflammation)
• Xentuzumab 750 mg + exemestane and everolimus (3 participants): 3 participants (100%)
• Xentuzumab 1000 mg + exemestane and everolimus (21 participants): 10 participants (48%)Too much sugar in the blood (hyperglycaemia)
• Xentuzumab 750 mg + exemestane and everolimus (3 participants): 3 participants (100%)
• Xentuzumab 1000 mg + exemestane and everolimus (21 participants): 10 participants (48%)Loss of energy (asthenia)
• Xentuzumab 750 mg + exemestane and everolimus (3 participants): 2 participants (67%)
• Xentuzumab 1000 mg + exemestane and everolimus (21 participants): 7 participants (33%)Rash
• Xentuzumab 750 mg + exemestane and everolimus (3 participants): 2 participants (67%)
• Xentuzumab 1000 mg + exemestane and everolimus (21 participants): 6 participants (29%)
Some unwanted effects were serious because they required a visit to hospital or a longer stay in hospital, were fatal, or were life-threatening. Unwanted effects were also serious if they led to disability, or the doctor thought they were serious for any other reason.
In part 1 of this study, 3 participants (14%) in the xentuzumab (1000 mg) with exemestane and everolimus group had serious unwanted effects.
Part 2:
In this document, we show only the numbers until 6 weeks after the treatment with xentuzumab was stopped in the study. Before this happened, 66 out of 70 participants (94%) in the xentuzumab with exemestane and everolimus group had unwanted effects. 66 out of 69 participants (96%) in the exemestane and everolimus alone group had unwanted effects.
The listing below shows the most common unwanted effects in part 2 of this study. The listing also shows how many participants had each of these unwanted effects.
Inflammation of the mucous linings (mucosal inflammation)
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 25 participants (36%)
• Exemestane and everolimus alone (69 participants): 21 participants (30%)Inflammation of the mouth (stomatitis)
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 24 participants (34%)
• Exemestane and everolimus alone (69 participants): 23 participants (33%)Rash
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 19 participants (27%)
• Exemestane and everolimus alone (69 participants): 19 participants (28%)Loss of energy (asthenia)
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 19 participants (27%)
• Exemestane and everolimus alone (69 participants): 19 participants (28%)Too much sugar in the blood (hyperglycaemia)
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 18 participants (26%)
• Exemestane and everolimus alone (69 participants): 15 participants (22%)Diarrhoea
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 18 participants (26%)
• Exemestane and everolimus alone (69 participants): 13 participants (19%)Diarrhoea
• Xentuzumab 1000 mg with exemestane and everolimus (70 participants): 18 participants (26%)
• Exemestane and everolimus alone (69 participants): 9 participants (13%)In part 2 of this study, 5 participants (7%) in the xentuzumab with exemestane and everolimus group had serious unwanted effects. 8 participants (12%) in the exemestane and everolimus group had serious unwanted effects.
Where can I find more information about this study?
You can find further information about this study at these websites:
1. Go to https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DouFFm-2FZqrUn2jjUD5TieZCEB1xiRFq0KhcCSxk9hEK0T3LVwaUyi31qRCR23p-2FH1-2BV3nIxyaWZun2xV7YsgUPw-3D-3D0VzM_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIPSD7gZEbyFSW-2BLfALeqtkaoYCwU-2BfMI7-2FpKcdrM8R-2B19WgDIvJBQZToyFgeLvfuAmvLtjfgctGKKx0yfaaOm-2BfBJThfNO2-2BtRZB2EA6KE91LY4NUq3FwFx6VPiBDxiDJwkudpaEJMnPcWsprYqk66WagWgdJeZYOXLpcRhspIBw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce33c63199bdd48d4401f08daef447d54%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638085374682016562%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=TetDfJ5u%2B9AD74LGWntKyDr4aABsHXjDN0pBqX0FVf8%3D&reserved=0 and search for the study number 1280.4.
2. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce33c63199bdd48d4401f08daef447d54%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638085374682016562%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=NLfwJPs0PyUgcOGUA4FmNfmlm%2Fc5bsrcFQk8arPkUg4%3D&reserved=0 and search for the EudraCT number 2013-001110-15.
3. Go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce33c63199bdd48d4401f08daef447d54%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638085374682016562%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=8jdr9WMm1Q%2FrujXzxfK0qDZmmirI0Ep0E8PW9lycj1g%3D&reserved=0 and search for the NCT number NCT02123823.
Boehringer Ingelheim sponsored this study.
The full title of the study is: ‘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’.
This study started in May 2014 and is still ongoing as of the date of this lay summary.Are there additional studies?
If we do more clinical studies with xentuzumab, you will find them on the websites listed above. To search for these studies, use the words xentuzumab or BI 836845.Important notice
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Usually, more than one study is carried out in order to find out how well a medicine works and the side effects of the medicine. Other studies may have different results.
You should not change your therapy based on the results of this study without first talking to your treating physician. Always consult your treating physician about your specific therapy.
Boehringer Ingelheim has provided this lay summary in accordance with European Union transparency obligations.
©2022 Boehringer Ingelheim International GmbH.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0073
Date of REC Opinion
17 Apr 2014
REC opinion
Further Information Favourable Opinion