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

Arm | Intervention/treatment |
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Active Comparator: Palbociclib (100mg)
Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
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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
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Drug: Palbociclib 125mg
125mg PO daily 3 weeks out of 4 Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor given at the standard doses/schedules |
- 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.
- 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.
- 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.
- Overall Survival [ Time Frame: 2 years ]Time from randomization to death of any cause.

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

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

Study Chair: | Anil A. Joy | Cross Cancer Institute, Edmonton Alberta Canada |
Documents provided by Canadian Cancer Trials Group:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |