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NCT02778685
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer
Phase 2 trial testing Fulvestrant in Metastatic Breast Carcinoma in 47 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2025
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 30 September 2016 |
| Primary completion | 31 October 2025 |
| Estimated completion | 30 March 2026 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Fulvestrant (fulvestrant) — full drug profile →
- Laboratory Biomarker Analysis
- Letrozole — full drug profile →
- Palbociclib (Palbociclib) — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Metastatic Breast Carcinoma — all drugs for Metastatic Breast Carcinoma →
- Stage IV Breast Cancer AJCC v6 and v7 — all drugs for Stage IV Breast Cancer AJCC v6 and v7 →
Sponsor
City of Hope Medical Center
Who can join
18 and older, female only, with Metastatic Breast Carcinoma or Stage IV Breast Cancer AJCC v6 and v7. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Fulvestrant blocks the use of estrogen by the tumor cells. Letrozole lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, palbociclib, and letrozole or fulvestrant may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cyclin D1, cancer progression, and opportunities in cancer treatment.
Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3 -
CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495 -
CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought.
Klein ME, Kovatcheva M, Davis LE, Tap WD, et al · · 2018 · cited 308× · PMID 29731395 · DOI 10.1016/j.ccell.2018.03.023 -
The Strange Case of CDK4/6 Inhibitors: Mechanisms, Resistance, and Combination Strategies.
Knudsen ES, Witkiewicz AK. · · 2017 · cited 218× · PMID 28303264 · DOI 10.1016/j.trecan.2016.11.006 -
Cyclin-dependent protein kinases and cell cycle regulation in biology and disease.
Pellarin I, Dall'Acqua A, Favero A, Segatto I, et al · · 2025 · cited 132× · PMID 39800748 · DOI 10.1038/s41392-024-02080-z -
Senescence as a therapeutically relevant response to CDK4/6 inhibitors.
Wagner V, Gil J. · · 2020 · cited 117× · PMID 32541838 · DOI 10.1038/s41388-020-1354-9 -
The Immunology of Hormone Receptor Positive Breast Cancer.
Goldberg J, Pastorello RG, Vallius T, Davis J, et al · · 2021 · cited 115× · PMID 34135901 · DOI 10.3389/fimmu.2021.674192 -
CDK4/6 Inhibitors: Game Changers in the Management of Hormone Receptor–Positive Advanced Breast Cancer?
Shah M, Nunes MR, Stearns V. · · 2018 · cited 96× · PMID 29847850
Verify or expand the search:
- PubMed search for NCT02778685
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fulvestrant
Trials testing the same drug.
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- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07368998 — To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer · Phase 2 · recruiting
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Other recruiting trials for Metastatic Breast Carcinoma
Currently open trials in the same condition.
- NCT07137416 — Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for H · Phase 1 · recruiting
- NCT06860815 — Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Br · Phase 2 · recruiting
- NCT06502691 — [18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Ca · Phase 1, PHASE2 · recruiting
- NCT07158021 — Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial · Phase 2 · recruiting
- NCT07227038 — Living Well With Advanced Breast Cancer · recruiting
Other City of Hope Medical Center trials
Trials by the same sponsor.
- NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02778685 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 24 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02778685.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing