New drug combo offers hope for elderly breast cancer patients avoiding surgery
NCT ID NCT02760030
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a combination of hormone therapy drugs (fulvestrant or an aromatase inhibitor) plus palbociclib in 14 elderly patients with hormone-responsive breast cancer who either had inoperable tumors or were too frail for surgery. The goal was to see if this drug-only approach could control the cancer without the need for surgery. The study measured how long patients stayed on treatment without it failing, and also tracked changes in cognitive function and overall well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fulvestrant or an aromatase inhibitor combined with palbociclib
- What this could lead to
- If successful, this drug combination could offer an effective non-surgical treatment option for elderly breast cancer patients who are too frail for surgery or choose not to have it.
- What could go wrong
- This is a small, early-phase trial with only 14 participants, so results may not apply to all patients. The combination may cause side effects like fatigue or low blood counts, and it is not a cure—patients will need ongoing treatment.
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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14 people
The number who actually took part.
- Started
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Feb 2017
- Finished
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Aug 2025
- 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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65 years and older
- Sex
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Female participants only
- 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: * Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by \> 10% staining by immunohistochemistry * Patients must be vulnerable or frail by Balducci Criteria or the patient is refusing breast surgery; vulnerable patients are defined as those with dependence in some instrumental activities of daily living, well controlled co-morbidities, and early symptoms of geriatric syndrome; frail patients are defined as those with three or more co-morbidities, dependence in one or more activities of daily living, or a clinically significant geriatric syndrome; geriatric syndromes include: dementia, delirium, incontinence (fecal and/or urinary), osteoporosis or spontaneous fractures, polypharmacy, visual/hearing impairment, sarcopenia and neglect or abuse * The patient's refusal to proceed with curative breast surgery has to be documented by the surgeon's and medical oncologist's note * Absolute neutrophil count (ANC) \> 1000/uL * Platelets \> 75,000/L * Serum creatinine 1.5 X institutional upper limit of normal (ULN) * Total bilirubin \< 1.5 X ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 2.5 ULN * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Prior aromatase inhibitor therapy * Evidence of distant metastases * Psychiatric illness, which would prevent the patient from giving informed consent * Patients receiving strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)
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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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Case Western University
Cleveland, Ohio, 44106, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
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