New drug cocktail aims to shrink breast tumors before surgery
NCT ID NCT03573648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining hormone therapy, a targeted drug (palbociclib), and an immunotherapy (avelumab) can shrink early-stage, hormone-positive breast tumors before surgery. About 33 women with stage II-III breast cancer will receive the treatment for about 4 months, then have surgery. The goal is to see if this approach leads to a complete response on MRI and is safe.
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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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33 people
The number who actually took part.
- Started
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Nov 2018
- 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: * Stage II-III ER-positive breast cancer * Tumor evaluable either by ultrasound or by touch. * Age ≥ 18 years. * Eastern Cooperative Oncology Group performance status of 1 or less. * Adequate organ and bone marrow function within 28 days prior to registration. * Females of child-bearing potential and males must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. * Females of child-bearing potential must have a negative pregnancy test within 7 days prior to registration on study. * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: * Evidence of metastatic disease or inflammatory breast cancer. * Patients not felt to be sensitive to endocrine therapy, such that a neoadjuvant endocrine-based approach would not be appropriate (i.e. PR-negative, high grade/Ki67, high gene expression profile, clinically aggressive presentation) * Previous treatment with endocrine therapy within the last 10 years (i.e. tamoxifen, aromatase inhibitors). * Previous treatment with CDK4/6 inhibitors, or immune checkpoint inhibitors. * Use of SSRIs and/or any concomitant use of medications outlined in section 6.5 within 4 days prior to enrollment. If patients are on stable doses and there are no good alternatives, the treating physician may discuss with Study Chair. * May not be receiving any other investigational agents. * May not be receiving immunosuppressive therapy within 2 weeks of study entry. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to corresponding endocrine therapy (tamoxifen, aromatase inhibitors, GnRH agonists), palbociclib, and avelumab are not eligible. * May not have had a prior diagnosis of cancer if it has been \< 3 years since their last treatment (with the exception of squamous cell carcinoma or basal cell carcinoma of the skin or cervical intraepithelial neoplasia). NOTE: Patients with a history of breast cancer or breast cancer treatment within the last 10 years are also excluded. Any previous radiation to affected breast is excluded. * Autoimmune disease within the last 3 years with the exception of: Vitiligo or alopecia; Hypothyroidism on stable doses of thyroid medication; and Psoriasis not requiring systemic therapy * Uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: Ongoing or active infection requiring systemic treatment (including HIV, TB, hepatitis viruses), symptomatic congestive heart failure, cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements, any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints * Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment 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 * Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines * Prior organ transplantation including allogenic stem-cell transplantation * Female patients who are pregnant or nursing are not eligible.
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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
Pittsburgh, Pennsylvania, 15224, United States
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Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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