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Trial record 1 of 1 for:    BTCRC-BRE15-016
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Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Big Ten Cancer Research Consortium
Sponsor:
Collaborators:
Pfizer
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Oana Danciu, MD, Big Ten Cancer Research Consortium
ClinicalTrials.gov Identifier:
NCT02668666
First received: January 27, 2016
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
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
Drug: Palbociclib
Drug: Tamoxifen
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-016

Resource links provided by NLM:


Further study details as provided by Big Ten Cancer Research Consortium:

Primary Outcome Measures:
  • Response Rates in Subjects with HR(+)/HER2(-) Advanced Breast Cancer who have not Received Prior Systemic Anti-Cancer Therapies for their Advanced/Metastatic Disease Treated with Palbociclib in Combination with Tamoxifen [ Time Frame: From start of treatment Day 1 (D1), assessed following completion of every two cycles of treatment for C3-19, and then following completion of every three cycles of treatment (C22+) (est. 18 months) ]
    Response Rates (partial response [PR] or complete response [CR]) will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or The University of Texas MD Anderson Cancer Center (MDA) Criteria (for patients with bone-only disease).


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From start of treatment D1 and every treatment visit thereafter (est. 18 months) ]
    Toxicity and tolerability of palbociclib and tamoxifen combination therapy, per Common Terminology Criteria for Adverse Events (CTCAE) v4

  • Progression-Free Survival (PFS) in Subjects with HR(+)/HER2(-) Advanced Breast Cancer who have not Received Prior Systemic Anti-Cancer Therapies for their Advanced/Metastatic Disease Treated with Palbociclib in Combination with Tamoxifen [ Time Frame: from the start of treatment D1 until the criteria for disease progression is met or death from any cause occurs. Subjects who have not progressed will be right-censored at the date of the last disease evaluation (est. 18 months) ]
    PFS rates will be assessed per RECIST 1.1 or MDA Criteria (for patients with bone-only disease).

  • Clinical Benefit Rate (CBR) in Subjects with HR(+)/HER2(-) Advanced Breast Cancer who have not Received Prior Systemic Anti-Cancer Therapies for their Advanced/Metastatic Disease Treated with Palbociclib in Combination with Tamoxifen [ Time Frame: From the start of treatment D1 assessed every 12 weeks +/- 1 week while on study treatment (est. 18 months) ]
    CBR (complete, partial response, or stable disease lasting 24 weeks or longer), assessed per RECIST 1.1 or MDA Criteria (for patients with bone only disease).

  • Overall Survival (OS) in Subjects with HR(+)/HER2(-) Advanced Breast Cancer who have not Received Prior Systemic Anti-Cancer Therapies for their Advanced/Metastatic Disease Treated with Palbociclib in Combination with Tamoxifen [ Time Frame: From time of registration to the time of subject death, assessed up to 24 months ]
    OS assessed using Kaplan-Meier Survival Analysis


Estimated Enrollment: 71
Actual Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Treatment

71 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
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.
Other Name: Ibrance
Drug: Tamoxifen
Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Other Name: Nolvadex

Detailed Description:

OUTLINE: This is a multi-center trial.

INVESTIGATIONAL TREATMENT:

  • Palbociclib 125 mg will be administered orally once daily on days 1-21 (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).

Palbociclib should be taken with food in combination with tamoxifen. Subjects should take their dose at approximately the same time each day.

It is encouraged, but not mandatory, that premenopausal subjects will also receive treatment with goserelin or equivalent (e.g., Lupron) given as an injectable subcutaneous implant on D1 of every 28 days cycle or every 3 months.

Disease assessments will be performed at the completion of every 2 cycles.

Treatment will continue until disease progression, unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for a total of 24 months after discontinuation of study drug.

To demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration for protocol therapy:

Hematological (must meet ALL of the following criteria):

  • Absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100 × 10 9/L

Renal (must meet ONE of the following criteria):

  • Serum creatinine ≤ 1.5 × ULN
  • Serum creatinine > 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 40 mL/min

Hepatic (must meet ALL of the following criteria):

  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases
  • Total serum bilirubin ≤ 1.5 × ULN
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following applicable inclusion criteria to participate in this study:

  • 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.
  • Women with locoregional recurrent or metastatic disease, as determined by biopsy of the metastatic lesion, not amenable to curative therapy.
  • Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER >1%, PR >1%), HER2 negative metastatic 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 (FISH, CISH, or SISH) 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. 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.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Provided written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information, approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC). NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  • Women of childbearing potential (WOCP) must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required within 72 hours of study registration from women of childbearing potential. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required.
  • Women of childbearing potential (WOCP) must be willing to use two effective methods of birth control such as use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the course of the study until 120 days after the last dose of study drug. The use of hormonal contraceptives is discouraged. NOTE: Women are considered to be of childbearing potential unless they are postmenopausal for at least 12 consecutive months or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

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.
  • Subjects with advanced, symptomatic, visceral spread that have 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.
  • Subjects with 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).
  • Subject has a 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.
  • Subject has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate subject participation in the clinical study.
  • Subject is currently receiving any of the following substances and cannot be discontinued 7 days prior to the start of the treatment:

    • 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.
  • Subject has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects of surgery.
  • Known history of human immunodeficiency virus [(HIV) HIV 1/2 antibodies].
  • Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) (testing not mandatory)
  • Any clinically significant infection defined as any acute viral, bacterial, or fungal infection that requires specific treatment. NOTE: Anti-infective treatment must be completed ≥ 7 days prior to study registration.
  • Any other severe, uncontrolled medical condition, including uncontrolled diabetes mellitus or unstable congestive heart failure
  • Known allergy to palbociclib or any of its excipients
  • Presence of any non-healing wound, fracture, or ulcer within 28 days prior to study registration.
  • Any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.
  • Any mental or medical condition that prevents the subject from giving informed consent or participating in the trial.
  • Treatment with any investigational agent within 28 days prior to registration for protocol therapy and the subject must have recovered from the acute toxic effects of the regimen.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02668666

Contacts
Contact: Oana Danciu, M.D. 312.996.1581 ocdanciu@uic.edu
Contact: Ahran Lee 317.634.5842 ext 14 alee@bigtencrc.org

Locations
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Oana Danciu, M.D.         
Contact: Joanna Hill    312-996-9272    joanhill@uic.edu   
United States, Michigan
Michigan State University Recruiting
Lansing, Michigan, United States, 48910
Contact: Karen Luellen    517-975-9534    Karen.Luellen@hc.msu.eduu.edu   
Principal Investigator: Deimante Tamkus, M.D.         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Erin Zielinski    612-624-0937    eezielin@umn.edu   
Principal Investigator: Anne Blaes, MD         
United States, Pennsylvania
Penn State Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Christina Rodriquez    717-531-5364    crodriguez1@hmc.psu.edu   
Principal Investigator: Cristina Truica, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Sandra Black    608-287-2032    Sandra.Black@uwmf.wisc.edu   
Principal Investigator: Kari Wisinski, MD         
Sponsors and Collaborators
Oana Danciu, MD
Pfizer
Hoosier Cancer Research Network
Investigators
Study Chair: Oana Danciu, M.D. Big Ten Cancer Research Consortium
  More Information

Additional Information:
Responsible Party: Oana Danciu, MD, Sponsor-Investigator, Big Ten Cancer Research Consortium
ClinicalTrials.gov Identifier: NCT02668666     History of Changes
Other Study ID Numbers: BTCRC BRE15-016
Study First Received: January 27, 2016
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Big Ten Cancer Research Consortium:
Palbociclib
Tamoxifen
CDK4/6 Inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones
Palbociclib
Tamoxifen
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2017