A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT04031885 |
Recruitment Status :
Terminated
(Business decision based on the inability to enroll subjects into the trial)
First Posted : July 24, 2019
Last Update Posted : October 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Breast Cancer | Drug: Abemaciclib Drug: Fulvestrant Drug: Standard Chemotherapy | Phase 4 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases |
Actual Study Start Date : | August 14, 2019 |
Actual Primary Completion Date : | August 11, 2020 |
Actual Study Completion Date : | August 11, 2020 |

Arm | Intervention/treatment |
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Experimental: Abemaciclib + Fulvestrant
Abemaciclib given orally and fulvestrant given by intramuscular (IM) injection.
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Drug: Abemaciclib
Administered orally
Other Name: LY2835219 Drug: Fulvestrant Administered IM |
Active Comparator: Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label.
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Drug: Standard Chemotherapy
Standard chemotherapy of physician's choice administered according to product label |
- Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 31 Months) ]ORR
- Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 31 Months) ]PFS
- Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 31 Months) ]TTR
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 31 Months) ]DoR
- PFS 2 [ Time Frame: Baseline to Second Objective Progression or Death Due to Any Cause (Estimated up to 62 Months) ]PFS 2

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must be females of post-menopausal status with HR+, HER2- breast cancer that has spread to internal organs
- Participants must have had at least one endocrine therapy
- Participants must be willing to use a device to answer daily questions about how they are doing for the duration of their participation in the study
- If participant has diarrhea from a previous treatment, they should talk to their doctor to ensure they have recovered enough to participate in this study
Exclusion Criteria:
- Participants must not have breast cancer that has spread to the brain if untreated and with symptoms
- Participants must not have had any systemic treatment after their breast cancer has spread unless it is endocrine therapy
- Participants must not have certain active infections including HIV or hepatitis
- Participants must not be pregnant or breastfeeding
- Participants must not have certain types of cancers or certain previous cancer treatments
- Participants must not have certain serious medical conditions, including heart or lung disease, or have had certain types of tissue or organ transplants

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031885

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04031885 |
Other Study ID Numbers: |
17320 I3Y-MC-JPCU ( Other Identifier: Eli Lilly and Company ) |
First Posted: | July 24, 2019 Key Record Dates |
Last Update Posted: | October 14, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | http://www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents, Hormonal |
Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |