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Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT02630693
Recruitment Status : Completed
First Posted : December 15, 2015
Results First Posted : August 7, 2019
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Description
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Brief Summary:
The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Palbociclib 100mg Drug: Palbociclib 125mg Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor Phase 2

Detailed Description:
The standard or usual treatment of this type of breast cancer is endocrine therapy. Palbociclib is a new type of drug for breast cancer. Laboratory tests as well as studies in animals and people show that it may help slow the growth of breast cancer. The most widely tested regimen of Palbociclib for patients with metastatic/advanced breast cancer is 125 mg every day for 21 days out of a 28 day cycle in combination with standard endocrine (hormone) therapy. This study explores if administering a lower dose of palbociclib - 100 mg given every day of a 28 day cycle in combination with standard endocrine (hormone) therapy - may result in more tumour shrinkage and be better tolerated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Comparing Two Different Schedules of Palbociclib Plus Second Line Endocrine Therapy in Women With Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Palbociclib (100mg)
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
 Drug: Palbociclib 100mg
100mg PO daily

Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor
given at the standard doses/schedules
Active Comparator: Palbociclib (125mg)
Palbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
 Drug: Palbociclib 125mg
125mg PO daily 3 weeks out of 4

Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor
given at the standard doses/schedules


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival Using the RECIST 1.1 Criteria [ Time Frame: 2 years ]
    progression free survival (PFS) is defined as time from randomization to progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Secondary Outcome Measures :
  1. Number of Participants With Response or No Response [ Time Frame: 2 years ]
    Response rate = Number of (Complete response + partial response) / total treated patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  2. Duration of Response [ Time Frame: 2 years ]
    For patients with complete or partial response, duration of response is defined as days from first recorded response to the first date of recurrent or progression or death.

  3. Overall Survival [ Time Frame: 2 years ]
    Time from randomization to death of any cause.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Premenopausal and postmenopausal women 18 years of age or older.
  • Histologically confirmed adenocarcinoma of the breast, with ER positive and HER2 negative status based on local testing on most recent pathological tumour specimen.

  • Patients must satisfy the following criteria for prior therapy:

    • Progressed during treatment or within 12 months of completion of adjuvant endocrine therapy or
    • Progressed during prior endocrine therapy for advanced/metastatic disease. Note: 'Progressed during endocrine therapy' means that the patient progressed while on or within 1 month after discontinuation of endocrine therapy.
  • One line of chemotherapy for advanced/metastatic disease (regardless of prior adjuvant chemotherapy use) is allowed in addition to endocrine therapy.
  • Patients must have evidence of disease to be eligible for the study, but measurable disease is not mandatory.

  • For those patient with measureable disease who will be included in the response assessment, the following criteria must apply:

    • X-ray ≥ 20 mm
    • Spiral CT scan or physical exam ≥ 10 mm (lymph nodes must be ≥ 15 mm in the short axis)
    • Conventional CT scan, MRI ≥ 20 mm
    • Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented.

Tumor lesions previously irradiated or subjected to other loco regional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.

  • Eastern Cooperative Oncology Group (ECOG) 0-2.

  • Adequate organ and bone marrow function as defined by:

    • ANC ≥ 1,500/mm3 (1.5 x 109/L)
    • Platelets ≥ 100,000/mm3 (100 x 109/L)
    • Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥60 ml/min as calculated using the method standard for the institution;
    • Total serum bilirubin ≤ 1.5 x ULN (<3 ULN if Gilbert's disease).
  • Patient must agree to provide tumour tissue from the most recent pathological tumour specimen.
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial.
  • In accordance with NCIC CTG policy, protocol treatment is to begin within 2 working days of patient randomization.
  • Women of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria:

  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term.
  • Patients with symptomatic CNS involvement, meningeal or parenchymal, that is uncontrolled or requires steroids.
  • Prior treatment with any CDK 4/6 inhibitor.
  • Prior treatment with mTOR inhibitors.
  • Active second malignancy, regardless of ongoing treatment.
  • Any concurrent medical condition that in the opinion of the investigator would interfere with the safe administration of the study drug and participation in the study.
  • Participation in a prior anti-cancer investigational study within 30 days prior to enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630693


Locations
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Sponsors and Collaborators
Canadian Cancer Trials Group
Pfizer
Investigators
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Study Chair: Anil A. Joy Cross Cancer Institute, Edmonton Alberta Canada
  Study Documents (Full-Text)

Documents provided by Canadian Cancer Trials Group:
Study Protocol  [PDF] July 5, 2017
Statistical Analysis Plan  [PDF] August 8, 2018

More Information
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT02630693    
Other Study ID Numbers: MA38
First Posted: December 15, 2015    Key Record Dates
Results First Posted: August 7, 2019
Last Update Posted: April 8, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Fulvestrant
Palbociclib
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Estrogen Receptor Antagonists
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors