Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (NCT03573648) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
United States33 participantsStarted 2018-11-13
Plain-language summary
Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Clinical Complete Response
Timeframe: 2 years
Trial details
NCT IDNCT03573648
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins