Clinical trial · Interventional
Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
Randomized Phase II Study of Fulvestrant With or Without Ganetespib in Patients With Hormone Receptor-Positive, Metastatic Breast Cancer
- 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)
Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments. It has also been studied in phase I trials, where the appropriate dosing has been determined. Ganetespib is considered an "HSP90 inhibitor". By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to become resistant to treatment. Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing so, it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the results of phase III clinical trials. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not known whether this is true in humans. In this research study, we are evaluating the effect of the addition of ganetespib to fulvestrant in participants with hormone receptor-positive, metastatic breast cancer.
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 |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Ganetespib | Drug | Ganetespib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM A - Fulvestrant
- description
- Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Eligible participants on Arm A were allowed to crossover to Arm B upon disease progression. Treatment continued for Arm A participants until 2nd disease progression.
- interventionNames
- Drug: Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- Arm B - Fulvestrant+Ganetespib
- description
- Fulvestrant: 500 mg administered by intramuscular injection on days 1 and 15 of cycle 1, day 1 of cycle 2 and each subsequent cycle; cycle duration is 28 days Ganetespib: 200 mg/m2 administered intravenously on days 1, 8 and 15 of each 28 day cycle Arm B participants whose disease was at a minimum stable could elect to discontinue ganetespib after 6 cycles or stay on combination treatment until disease progression. Otherwise, Arm B participants taken off ganetespib for toxicity were to remain on single agent fulvestrant until disease progression.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced * Estrogen and/or progesterone receptor positive breast cancer * HER2 negative * Measurable disease is required (effective 4/30/14: all non-measurable \[evaluable\] disease slots have been filled) * Endocrine resistant breast cancer * May have received up to one prior line of chemotherapy for metastatic or unresectable locally advanced breast cancer * May have initiated bisphosphonate therapy prior to start of protocol therapy * Must be at least 2 weeks from prior chemotherapy or radiotherapy * ECOG performance status of 0 or 1 * Availability of tissue block from initial breast cancer diagnosis and/or metastatic recurrence * For subjects with biopsy-accessible disease, must be willing to undergo a required on-treatment research biopsy * Adequate IV access Exclusion Criteria: * Pregnant or breastfeeding * Prior treatment with HSP90 inhibitor * Prior treatment with fulvestrant * Concurrent treatment with commercial agents or other agents with the intent to treat the participant's malignancy * Untreated or progressive brain metastases * Pending visceral crisis, in the opinion of the treating investigator * History of allergic reactions attributed to compounds of similar chemical or biologic composition to fulvestrant or ganetespib * Uncontrolled intercurrent illness * Other malignancies within 3 years
References
Publications (0)
Data not yet available