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

  • STATUS
    Recruiting
  • End date
    Dec 13, 2022
  • participants needed
    25
  • sponsor
    National Taiwan University Hospital
Updated on 13 May 2021

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. 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.

Details
Condition Premenopausal Breast Cancer
Treatment Pembrolizumab/ Exemestane/ Leuprolide
Clinical Study IdentifierNCT02990845
SponsorNational Taiwan University Hospital
Last Modified on13 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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