Clinical trial · Interventional
Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
Phase 2a, Open-Label, Randomized, Noncomparative Study of BIIB021 in Combination With Exemestane in Women With Hormone Receptor-Positive, Advanced Metastatic Breast Cancer Who Have Progressed on a Nonsteroidal Aromatase Inhibitor
NCT01004081CI-TRIAL-00019310completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (AI).
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIIB021 | Drug | — | UNRESOLVED |
| exemestane (Aromasin) | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIIB021 BID + exemestane
- description
- BIIB021 100 mg BID + exemestane 25 mg QD
- interventionNames
- Drug: BIIB021
- Drug: exemestane (Aromasin)
- type
- EXPERIMENTAL
- label
- BIIB021 TIW + exemestane
- description
- BIIB021 450 mg TIW + exemestane 25 mg QD
- interventionNames
- Drug: BIIB021
- Drug: exemestane (Aromasin)
Primary outcomes (1)
- measure
- The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years of age * Must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer. * Must have disease progression during treatment with a nonsteroidal AI for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting. * Must be a postmenopausal female. * Must have measurable or evaluable disease. * Measurable disease is defined as \>=1 lesion with a diameter of \>=10 mm * Evaluable disease is defined as bone lesions evaluable by plain X ray, CT scan, or MRI. Lesions identified only by radionuclide bone scan are not allowed. * One prior chemotherapy regimen for advanced mBC is allowed. * Prior radiotherapy is allowed. * Must be able to swallow and retain oral medication. * ECOG performance status of \<=2 * Required laboratory values * Plasma cortisol and adrenocorticotropic hormone (ACTH) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency. Exclusion Criteria: * HER2 overexpressing tumor. * History of central nervous system (CNS) metastasis. * Previous treatment with exemestane or treatment with an Hsp90 inhibitor. * Use of proton pump inhibitors. * Known history of or positive test result for hepatitis B or C or HIV. * History of gastrectomy or major surgery to small intestine.
References
Publications (0)
Data not yet available
No reference posted for this study.