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NCT02040857
A Phase 2 Pilot Feasibility Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive Invasive Breast Carcinoma
Phase 2 trial testing Palbociclib in Breast Cancer in 162 participants. Completed in 27 December 2024.
1 May 2018
Quick facts
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 162 |
| Start date | 1 January 2014 |
| Primary completion | 1 May 2018 |
| Estimated completion | 27 December 2024 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Palbociclib (Palbociclib) — full drug profile →
- Aromatase Inhibitor (aromatase-inhibitor) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Dana-Farber Cancer Institute
Who can join
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
2-Year Treatment Discontinuation Rate
Time frame: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.
The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.
Sponsor's own description
This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer. * Palbociclib is a drug that may stop cancer cells from growing. Palbociclib blocks activity of two closely related enzymes (proteins that help chemical reactions in the body occur), called Cyclin D Kinases 4 and 6 (CDK 4/6). These proteins are part of a pathway, or a sequence of steps which is known to regulate cell growth. Laboratory testing has suggested palbociclib may stop the growth of hormone receptor positive breast cancer. * Endocrine therapy prevents breast cancer cell growth by blocking estrogen stimulation. During this study endocrine therapy will either be tamoxifen or an aromatase inhibitor. It is standard of care for premenopausal women to take tamoxifen and for postmenopausal women to take either an aromatase inhibitor or tamoxifen after a diagnosis of hormone receptor positive breast cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 -
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 -
Mechanisms of resistance in estrogen receptor positive breast cancer: overcoming resistance to tamoxifen/aromatase inhibitors.
Mills JN, Rutkovsky AC, Giordano A. · · 2018 · cited 99× · PMID 29719270 · DOI 10.1016/j.coph.2018.04.009 -
Palbociclib: an evidence-based review of its potential in the treatment of breast cancer.
Cadoo KA, Gucalp A, Traina TA. · · 2014 · cited 71× · PMID 25177151 · DOI 10.2147/bctt.s46725 -
Targeting the cyclin D-cyclin-dependent kinase (CDK) 4/6-retinoblastoma pathway with selective CDK 4/6 inhibitors in hormone receptor-positive breast cancer: rationale, current status, and future directions.
Spring L, Bardia A, Modi S. · · 2016 · cited 64× · PMID 26896604 -
Functionalized Nanoparticles Targeting Tumor-Associated Macrophages as Cancer Therapy.
He Y, de Araújo Júnior RF, Cruz LJ, Eich C. · · 2021 · cited 48× · PMID 34683963 · DOI 10.3390/pharmaceutics13101670 -
The evolution of cyclin dependent kinase inhibitors in the treatment of cancer.
Jhaveri K, Burris Rd HA, Yap TA, Hamilton E, et al · · 2021 · cited 40× · PMID 34176404 · DOI 10.1080/14737140.2021.1944109
Verify or expand the search:
- PubMed search for NCT02040857
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Palbociclib
Trials testing the same drug.
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Currently open trials in the same condition.
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Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
- NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention · NA · not yet recruiting
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- NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0) · Phase 2 · 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 NCT02040857 (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 Dana-Farber Cancer Institute
- Last refreshed: 23 April 2025
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/NCT02040857.
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