Clinical trial · Interventional
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision based on the inability to enroll subjects into the trial
Summary
Brief summary (as posted)
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has spread to internal organs. Your participation in this trial could last up to 31 months, depending on your cancer type and how you and your tumor respond.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Standard Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abemaciclib + Fulvestrant
- description
- 150 milligram (mg) Abemaciclib given orally twice a day (BID) with 500 mg fulvestrant given by intramuscular (IM) injection on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then Day 1 of each subsequent cycle.
- interventionNames
- Drug: Abemaciclib
- Drug: Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- Standard Chemotherapy
- description
- Standard chemotherapy of physician's choice (capecitabine, docetaxel, nab paclitaxel, or paclitaxel), administered according to product label.
- interventionNames
- Drug: Standard Chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available