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

NCT02630693 | Completed Phase 2 Results DMC

• 1 other identifier: MA38
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 22

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Using the RECIST 1.1 Criteria

  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.

  2 years

Secondary Outcomes (3)

• Number of Participants With Response or No Response

  2 years

• Duration of Response

  2 years

• Overall Survival

  2 years

Study Arms (2)

Palbociclib (100mg)

ACTIVE COMPARATOR

Palbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules

Drug: Palbociclib 100mg; Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor

Palbociclib (125mg)

ACTIVE COMPARATOR

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; Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor

Interventions

Palbociclib 100mg DRUG

100mg PO daily

Palbociclib (100mg)

Palbociclib 125mg DRUG

125mg PO daily 3 weeks out of 4

Palbociclib (125mg)

Fulvestrant or Tamoxifen or Aromatase Inhibitor DRUG

given at the standard doses/schedules

Palbociclib (100mg); Palbociclib (125mg)

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Pfizer: collaborator

Study Sites (22)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Abbotsford Centre

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

Location

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2S 0A9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Joy AA, Cheng N, Gelmon KA, Mates M, Desbiens C, Clemons M, Taylor S, Lemieux J, DeLuca A, Gasparini L, Lungu I, Soave D, Fortuna A, Pugh T, Liu SS, Bartlett JMS, Awadalla P, Spears M, Chen BE, Bayani J, Parulekar WR. Continuous versus Standard Palbociclib Treatment and Molecular Profiling of Solid Tissues and Liquid Biopsies in the CCTG MA.38 Trial in Advanced Breast Cancer. Cancer Res Commun. 2025 Nov 1;5(11):1998-2011. doi: 10.1158/2767-9764.CRC-25-0346.

  PMID: 41123599 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib; Fulvestrant; Tamoxifen; Aromatase Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr. Wendy Parulekar
• Organization: Canadian Cancer Trials Group

wparulekar@ctg.queenus.ca

613-533-6430

Study Officials

• Anil A. Joy

  Cross Cancer Institute, Edmonton Alberta Canada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: April 8, 2016
• Primary Completion: August 15, 2018
• Study Completion: November 29, 2023
• Last Updated: April 13, 2026
• Results First Posted: August 7, 2019

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (22)