Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03573648 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer

Study acronym: ImmunoADAPT
StatusActive, Not Recruiting
PhasePhase 2
Started2018-11-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 30, 2026
See other at-risk trials from Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Amendment history

2026-09-25
Primary completion pushed: 2026-09-30 → 2026-12-30
Completion pushed: 2026-12-30 → 2027-03-30
2026-03-17
Study Status v14
Primary completion date2026-03-30→2026-09-30
Completion date2026-06-30→2026-12-30
2025-09-19
Study Status v13
Primary completion date2025-09-30→2026-03-30
Completion date2025-12-31→2026-06-30
2025-03-04
Study Status v12
Primary completion date2025-03-31→2025-09-30
2024-09-16
Study Status v11
Primary completion date2024-07-31→2025-03-31
Show 10 earlier versions
2024-03-26
Study Status v10
Primary completion date2023-12-31→2024-07-31
Completion date2023-12-31→2025-12-31
2023-03-07
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-12→2023-12-31
Completion date2022-12→2023-12-31
Enrollment targetestimated 40→confirmed 33
Study sitesdetails revised at 4 of 4 sites
2022-04-15
2 amendments v7-v8
2 re-verifications since 2022-01-10, no change to tracked fields
2021-05-28
Study Status, Contacts/Locations v6
Study sites2→4
2021-02-23
Study Status v5
Primary completion date2021-12→2022-12
Completion date2021-12→2022-12
2020-12-28
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v4
Primary completion date2020-12→2021-12
Completion date2020-12→2021-12
Study sites1→2
InterventionsAvelumab (Drug), Palbociclib (Drug), Tamoxifen (Drug)→Avelumab (Drug), Endocrine therapy (Drug), Palbociclib (Drug)
Eligibility criteria+475 characters
[...] ts not felt to be sensitive to endocrine therapy, such that a neoadjuvant endocrine-based approach would not be appropriate (i.e.g. PR-negative, high grade/Ki67, high gene expression profile, clinically aggressive presentation, low ER or PR, high proliferation). Previous treatment with endocrine therapy within the last 1 [...] nt 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 w [...] [...]
Study description+420 characters
Patients will be treated with tamoxifenendocrine (20mg PO daily)therapy +/- palbociclib (125mg, POtaken orally, daily for 21 days, 7 days off ) for 1 cycle (1 cycle =28 da [...] ys). Patients will be treated for 3 cycles of avelumab with tamoxifenendocrine therapy +/- palbociclib (thus 4 cycles total, including run-in without avelumab). The kind of endocrine therapy given will depend on menopausal status and will be a standard treatment. For premenopausal women, the endocrine therapy will be daily tamoxifen (20mg taken orally daily for 28 days), plus either Leuprolide (3.75mg taken intramuscularly) o [...] [...]
Study title+8 characters
Neoadjuvant TamoxifenEndocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
2020-02-27
Study Identification, Study Status, Sponsor/Collaborators, Eligibility v3
Primary completion date2020-08→2020-12
Completion date2020-08→2020-12
Eligibility criteria+887 characters
Inclusion Criteria: Stage II-III ER-positive breast cancer Tumor evaluable either by ultrasound or by touch. Age ≥ 18 years. Eastern Cooperative Oncology Group perform [...] disease or inflammatory breast cancer. Patients not felt to benefitbe fromsensitive to endocrine therapy, such that endocrine approach would not be appropriate (ie.eg. clinically aggressive presentation, low ER or PR, high proliferation). Previous treatment with endocrine therapy within the last [...] ded. Any previous radiation to affected breast is excluded. - Autoimmune disease within the last 3 years with the exception of: Vitiligo [...] [...]
Collaborators1 to 3 entries
Allegheny Health Network National Institutes of Health (NIH)
2019-08-29
Study Status v2
Re-verified, no change to tracked fields
2018-11-20
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-08→confirmed 2018-11-13
Study sitesdetails revised at 1 of 1 site
2018-06-20
Original filing
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.
Trial Details
NCT Number NCT03573648
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Pfizer, Allegheny Health Network, National Institutes of Health (NIH)
Conditions Breast Cancer
Enrollment 33 participants
Start Date 2018-11-13
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-24