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Breast CancerPhase 2NCT02630693

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

A Phase 2 study testing Palbociclib 100mg, Palbociclib 125mg and Fulvestrant or Tamoxifen or Aromatase Inhibitor in people with Breast Cancer, run by Canadian Cancer Trials Group at 22 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Palbociclib 100mg, Palbociclib 125mg and Fulvestrant or Tamoxifen or Aromatase Inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
22 sitesCanada
Study dates
8 Apr 2016to 29 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Canada22 sites

  • BCCA - Abbotsford Centre

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

  • Dr. H. Bliss Murphy Cancer Centre

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

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Palbociclib 100mg, Palbociclib 125mg, Fulvestrant or Tamoxifen or Aromatase Inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib 100mgDrug

    100mg PO daily

  • Palbociclib 125mgDrug

    125mg PO daily 3 weeks out of 4

  • Fulvestrant or Tamoxifen or Aromatase InhibitorDrug

    given at the standard doses/schedules

Study groups in NCT02630693
Study groupRoleWhat they receive
Palbociclib (100mg)Active comparatorPalbociclib 100mg PO daily plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Receives: Drug: Palbociclib 100mg; Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor
Palbociclib (125mg)Active comparatorPalbociclib 125mg PO daily 3 out of 4 weeks plus Fulvestrant or Tamoxifen or another Aromatase Inhibitor at the standard doses/schedules
Receives: Drug: Palbociclib 125mg; Drug: Fulvestrant or Tamoxifen or Aromatase Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (3)

  1. Number of Participants With Response or No Response

    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.

    Measured: 2 years

  2. Duration of Response

    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.

    Measured: 2 years

  3. Overall Survival

    Time from randomization to death of any cause.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2015 (estimated)
  2. Study start8 Apr 2016
  3. Primary completion15 Aug 2018
  4. Study completion29 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630693
Sponsor's protocol ID
MA38
Status last verified
Nov 2025
First submitted
11 Dec 2015
Last updated
13 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41123599

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib 100mg, Palbociclib 125mg and Fulvestrant or Tamoxifen or Aromatase Inhibitor in people with Breast Cancer, run by Canadian Cancer Trials Group at 22 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival Using the RECIST 1.1 Criteria (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02630693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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Clinical Trial NCT02630693 | AzTrials