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Premenopausal Breast CancerPhase 1/2PEERNCT02990845

Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer

A Phase 1/2 study testing Pembrolizumab/ Exemestane/ Leuprolide in people with Premenopausal Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 (HER2) negative breast cancer. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Premenopausal Breast Cancer
What is being tested?
Pembrolizumab/ Exemestane/ Leuprolide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteTaiwan
Study dates
15 Sep 2017to 16 Aug 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

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

Who may be able to join

  • Be a female adult aged more than 20-year-old at the time of informed consent.
  • Have histologically confirmed ER positive (defined as ≥1%) and/ or PR positive (defined as ≥1%) breast cancer.
  • Have histologically confirmed HER2-negative breast cancer as defined by IHC ≤ 2+, and/or FISH negative.
  • Have radiological or objective evidence of inoperable locally advanced or metastatic breast cancer.
  • Be premenopausal or peri-menopausal. Premenopausal or peri-menopausal status is defined as below:
  • Last menstrual period within the last 12 months OR
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  • With a plasma estradiol ≥10pg/ml and FSH ≤40IU/L
  • Be resistant to front line hormonal therapy, as defined as one of the following criteria:
  • Have become inoperable locally advanced or metastatic disease within one year of adjuvant hormonal therapy.
  • Fail at least 2 line of prior hormonal therapy for locally advanced or metastatic breast cancer.
  • Have history of disease progressed within 6 months during 1st line hormone therapy for locally advanced or metastatic disease.
  • Prior exemestane usage is allowed, but the patient number is limited to ≤10 patients.
  • Have archival primary tumor specimen from diagnosis.
  • Have metastatic tumor specimen before enrollment.
  • Have measurable disease as per RECIST 1.1 or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.
  • Have ECOG performance status 0 or 1 assessed within 10 days of treatment initiation.
  • Have adequate bone marrow and organ function.
  • For women of childbearing potential must have a negative serum beta-hCG or urine pregnancy test obtained within 3 days before starting treatment.
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section - Contraception, for the course of the study through 120 days after the last dose of study medication.
  • Be able to comply with study procedures and sign an informed consent.

Who cannot join

  • Is currently participating in an investigational agent study.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment. Physiological steroid replacement is allowed.
  • Has had chemotherapy within 2 weeks prior to the first dose of study treatment or has not recovered from side effects (i.e. Grade 1 at baseline) except alopecia related to prior therapy.
  • Is a hepatitis B or C carrier.
  • Has concurrent malignancy other than non-melanoma skin cancer.
  • Is not able to undergo metastatic tumor biopsy.
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  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) or has previously participated in Merck pembrolizumab clinical trials.
  • Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
  • Is lactating, pregnant, or unwilling to employ birth control methods during the study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: A Pilot Study of Pembrolizumab and Exemestane/ Leuprolide in Premenopausal Hormone Receptor Positive/ HER2 Negative Locally Advanced or Metastatic Breast Cancer

This is an open-label, single-arm, multicenter, pilot study of pembrolizumab, exemestane, and leuprolide for subjects being resistant for front-line hormonal therapy for inoperable locally advanced or metastatic hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 (HER2) negative breast cancer. All the patients will be included in the final tolerability and preliminary efficacy analysis. The efficacy objectives including PFS, overall response rate (ORR), clinical benefit rate (CBR), and duration of response (DOR). Adverse effects will be recorded according to CTCAE v4.0.

Being tested
Pembrolizumab/ Exemestane/ Leuprolide

What participants receive

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

  • Pembrolizumab/ Exemestane/ LeuprolideDrug

    Dose level 1 (Pembrolizumab 150 mg IV Q2W); Dose level -1 (Pembrolizumab 100 mg IV Q2W); Dose level -2 (Pembrolizumab 50 mg IV Q2W) Combination with Exemestane 25 mg PO QD, and Leuprolide 3.75 mg SC Q4W

Study groups in NCT02990845
Study groupRoleWhat they receive
Pembrolizumab/ Exemestane/ LeuprolideExperimentalDose level 1 (Pembrolizumab 150 mg IV Q2W); Dose level -1 (Pembrolizumab 100 mg IV Q2W); Dose level -2 (Pembrolizumab 50 mg IV Q2W) Combination with Exemestane 25 mg PO QD, and Leuprolide 3.75 mg SC Q4W
Receives: Drug: Pembrolizumab/ Exemestane/ Leuprolide

What is being measured

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

  1. The PFS rate at 8 months

    To estimate the efficacy of the combination of pembrolizumab and exemestane/ leuprolide in premenopausal with hormone receptor positive/ HER2 negative locally advanced or metastatic breast cancer patients, as defined by PFS rate at 8 months.

    Measured: 28 months

Secondary outcomes (5)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 28 months

  2. The PFS based on RECIST 1.1

    Measured: 28 months

  3. The overall response rate (ORR) based on RECIST 1.1

    Measured: 28 months

  4. The clinical benefit rate (CBR) based on RECIST 1.1

    Measured: 28 months

  5. The duration of overall response (DOR) based on RECIST 1.1

    Measured: 28 months

Timeline

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

  1. First posted13 Dec 2016 (estimated)
  2. Study start15 Sep 2017
  3. Primary completion16 Aug 2022
  4. Study completion16 Aug 2022

Why it stopped: The enrolment became difficult, as most of the premenopausal women decided to receive ovarian ablation for health insurance reimbursement for CDK4/6 inhibitor for the first-line treatment, making them ineligible for joining the study.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02990845
Sponsor's protocol ID
201610003MIFA
Acronym
PEER
Status last verified
Feb 2023
First submitted
1 Dec 2016
Last updated
22 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen IC, Lin CH, Chang DY, Wei-Wu Chen T, Wang MY, Ma WL, Lin YT, Huang SM, Hsu CL, Lu YS. Hormone therapy enhances anti-PD1 efficacy in premenopausal estrogen receptor-positive and HER2-negative advanced breast cancer. Cell Rep Med. 2025 Jan 21;6(1):101879. doi: 10.1016/j.xcrm.2024.101879. Epub 2024 Dec 26.

    PubMed 39730000

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab/ Exemestane/ Leuprolide in people with Premenopausal Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

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 20 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: The enrolment became difficult, as most of the premenopausal women decided to receive ovarian ablation for health insurance reimbursement for CDK4/6 inhibitor for the first-line treatment, making them ineligible for joining the study.). Results are not available in the source record.

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?

The PFS rate at 8 months (time frame: 28 months). 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 NCT02990845, 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 22 Feb 2023.

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