Can switching hormone drugs stall breast cancer when first treatment fails?
NCT ID NCT02738866
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether continuing the drug palbociclib (Ibrance) while switching to a different hormone therapy, fulvestrant (Faslodex), can help control metastatic breast cancer in people whose disease has worsened on palbociclib plus an aromatase inhibitor. The study enrolls 60 adults with hormone receptor-positive, HER2-negative advanced breast cancer. Researchers will measure how long the cancer stays under control and look for genetic mutations that might affect response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Palbociclib (Ibrance) and fulvestrant (Faslodex)
- What this could lead to
- If successful, this could show that continuing palbociclib with a different hormone therapy helps control metastatic breast cancer for longer after initial treatment stops working.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. It may not show meaningful benefit, and side effects like low blood cell counts or fatigue are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Oct 2016
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women may be premenopausal or postmenopausal * Metastatic or locally advanced breast cancer, not amenable to surgery or radiation with curative intent * ER-positive and/or PR-positive, HER2-negative tumor * Prior treatment: progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy; up to one (1) prior line of chemotherapy for advanced disease is allowed in addition to any number of prior lines of endocrine therapy; no prior treatment with fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway in the metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Evaluable or measurable disease * Disease that is amenable to biopsy * Adequate hematologic and renal function * History of central nervous system metastasis is allowed if treated and stable * Prior radiation therapy is allowed if recovered from toxicity and disease evaluable for response outside of the radiation fields or evidence of post-radiation progression of previously irradiated sites of disease * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * Women who are pregnant or breast-feeding * Concurrent use of inhibitors or inducers of CYP3A4, or medications which prolong the QTc interval * Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration; prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received * Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix * Any severe cardiac event within 6 months of registration * Prior hematopoietic stem cell or bone marrow transplantation * Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if applicable) * Known or possible hypersensitivity to palbociclib, fulvestrant, goserelin (if applicable) or to any of their excipients * Known human immunodeficiency virus infection * Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allegheny Health Network (AHN) - Allegheny General Hospital ONLY
Pittsburgh, Pennsylvania, 15212, United States
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Anne Arundel Health System Research Institute, Inc.
Annapolis, Maryland, 21401, United States
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Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania, 19611, United States
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a blood test reveal when breast cancer treatment stops working?
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- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?