Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

NCT02668666 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BTCRC BRE15-016
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief Summary

This is a non-randomized, open-label, single-arm, multicenter, phase II study of palbociclib in combination with tamoxifen in women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anticancer therapies for their advanced/metastatic disease.

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Estrogen Receptor Positive Breast Cancer; Progesterone Receptor Positive Tumor; Metastatic Breast Cancer

Keywords

Palbociclib; Tamoxifen; CDK4/6 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Per RECIST 1.1

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

  Time of treatment start until the criteria for disease progression or death. Up to a maximum of 61 months.

Secondary Outcomes (4)

• Adverse Events

  Adverse events (AEs) had been recorded from the time of consent until 30 days after discontinuation of study drug(s), up to a maximum of 56 months.

• Objective Response Rates (ORR)

  Up to a maximum of 61 months.

• Clinical Benefit Rate (CBR)

  Up to a maximum of 61 months.

• Overall Survival (OS)

  2 years

Study Arms (1)

Investigational Treatment

EXPERIMENTAL

Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Drug: Palbociclib; Drug: Tamoxifen

Interventions

Palbociclib DRUG

Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28.

Also known as: Ibrance

Investigational Treatment

Tamoxifen DRUG

Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).

Also known as: Nolvadex

Investigational Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age at time of consent. NOTE: Both pre- and post-menopausal women are eligible. Pre-menopausal status is defined as either:
• Last menstrual period within the last 12 months.
• In case of therapy-induced amenorrhea, plasma estradiol and /or FSH is in the premenopausal range per local normal range.
• Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to curative therapy. NOTE: Although not required as a protocol procedure, a patient with a new metastatic lesion should be considered for biopsy whenever possible to reassess ER/PR/HER2 status if clinically indicated. If a biopsy is prospectively done as part of standard of care, the study would like to store samples for correlative research.
• Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER \>1%, PR \>1%), HER2 negative breast cancer. NOTE: Subject has HER2-negative breast cancer (based on most recently analyzed biopsy) is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (e.g. FISH, CISH, SISH, DISH, etc.) test is required by local laboratory testing.
• Metastatic disease evaluable on imaging studies. Subjects may have measurable disease as per RECIST 1.1 or bone-only disease. NOTE: Bone-only subjects are eligible if their disease can be documented/ evaluated by bone scans, CT or MRI. Their disease will be assessed using MDA criteria. NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation.
• No prior systemic anti-cancer therapy for advanced HR+ disease. NOTE: Subjects receiving adjuvant treatment with aromatase inhibitors at time of recurrence are allowed to participate. There is no AI washout period required.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Adequate hepatic function within 14 days prior to registration for protocol therapy defined as meeting all of the following criteria:
• aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases and
• alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases and
• total serum bilirubin ≤ 1.5 × ULN
• Adequate renal function within 14 days prior to registration for protocol therapy defined by either of the following criteria:
• serum creatinine ≤ 1.5 × ULN
• OR if serum creatinine \> 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min

You may not qualify if:

• Subjects meeting any of the criteria below may not participate in the study:
• Prior treatment with any CDK 4/6 inhibitor.
• Confirmed diagnosis of HER2 positive disease.
• Known uncontrolled or symptomatic CNS metastases. Subjects with known brain metastasis will only be eligible after their tumors have been treated with definitive resection and /or radiotherapy and they are neurologically stable for at least 1 month off steroids.
• Advanced, symptomatic, visceral spread with a life expectancy less than 4 months.
• Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
• Prior history of blood clots, pulmonary embolism or deep vein thrombosis.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
• Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate subject participation in the clinical study.
• Currently receiving any of the following substances and cannot be discontinued 7 days prior to study registration:
• Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges.
• Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
• Known strong inducers or inhibitors of CYP2D6.
• Major surgery within 14 days prior to study registration or has not recovered from major side effects of surgery.

Sponsors & Collaborators

• Oana Danciu, MD: lead
• Pfizer: collaborator
• Big Ten Cancer Research Consortium: collaborator

Study Sites (7)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

Michigan State University

Lansing, Michigan, 48910, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

Related Links

• Big Ten Cancer Research Consortium Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Fauzia Sharmin
• Organization: Hoosier Cancer Research Network

fsharmin@hoosiercancer.org

317-921-2050

Study Officials

• Oana Danciu, M.D.

  Big Ten Cancer Research Consortium

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: February 1, 2017
• Primary Completion: July 3, 2023
• Study Completion: October 24, 2023
• Last Updated: January 20, 2026
• Results First Posted: July 29, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)