Breast CancerPhase 2NCT03393845
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
A Phase 2 study testing Pembrolizumab and Fulvestrant in people with Breast Cancer, run by Nancy Chan, MD at 5 sites in United States.
Trial summary
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pembrolizumab and Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jan 2018to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Men [29] and women ≥ 18 years of age at the time of informed consent. NOTE: Both pre- and post-menopausal women are eligible. Patients who are premenopausal should either undergo bilateral oophorectomy or receive ovarian suppression according to institutional standards. Male patients will be treated as premenopausal females and receive a GnRH agonist.
- ECOG Performance Status of 0 or 1 within 28 days prior to registration.
- Histologic or cytologic diagnosis of metastatic breast cancer.
- Has received no more than two lines of prior therapy for advanced non-resectable/metastatic disease. Prior lines can can be either chemotherapy or hormonal therapy. Prior or current fulvestrant is allowed. Combination therapy is considered as one regimen.
Show all 28Show fewer
- Tumor is estrogen receptor positive (ER+) and/or (PR+), HER-2 negative (HER2-). ER and PR positivity is defined as >1%. HER-2 negative is defined as by IHC (0, 1+) or FISH. HER2 positive test result includes: Single-probe average HER2 copy number ≥6.0 signals/cell; Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2; copy number ≥4.0 signals/cell; Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2copy number <4.0 signals/cell; or Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number ≥6.0 signals/cell. Equivocal findings for IHC as 2+ should be reflexed to FISH. Equivocal results by FISH may be considered with approval from the Sponsor-Investigator.
- Measurable disease based on RECIST 1.1 within 28 days prior to registration. Except in patients with bone-only disease, in the absence of measurable disease, evaluable bone lesion is allowed. NOTE: Bone-only disease is the sole non-measurable disease site allowed and biopsy is required. Measurable disease is required in all other cases.
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. NOTE: Subjects for whom newly-obtained fresh tissue samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor-Investigator.
- Normal cardiac function as determined by treating physician per institutional standards via echocardiogram (ECHO) performed within 28 days prior to registration.
- Prior chemotherapy must be completed at least 28 days prior to registration or at least 14 days prior to registration for targeted therapy.
- Prior hormonal therapy or radiation therapy must be completed at least 14 days prior to registration. If subject is currently receiving fulvestrant, it may continue without interruption as per standard of care.
- The subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. NOTE: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. NOTE: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to study registration, as determined by the enrolling physician.
- Demonstrate adequate organ function as defined in the table below; all screening labs will be performed within 28 days of study registration.
- Hematological
- Absolute Neutrophil Count (ANC): ≥ 1500/mm3
- Platelets: ≥100,000 / mcL
- Hemoglobin (Hgb): ≥ 9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
- Renal
- ---Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥30 mL/min for subjects with creatinine levels > 1.5 × institutional ULN
- Hepatic
- Serum total bilirubin: ≤ 1.5 X ULN OR
- Direct bilirubin ≤ ULN for subjects with total bilirubin levels: > 1.5 ULN
- AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN
- Albumin: >2.5 mg/dL
- Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance will be calculated per institutional standard.
- Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to study registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See the protocol for definitions. NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Females and males of reproductive potential must be willing to abstain from heterosexual activity which could result in pregnancy or agree to use an adequate method of contraception as outlined in the protocol. Hormonal contraceptives are contraindicated in this population and are not allowed. Contraception will begin from the time of informed consent through 120 days after the last dose of study drug(s).
Who cannot join
- Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a known history of active TB (Bacillus Tuberculosis). NOTE: TB testing is not required.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). NOTE: HIV testing is not required.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
Show all 20Show fewer
- NOTE: Hepatitis B and Hepatitis C testing is not required.
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has received prior chemotherapy within 28 days prior to study registration or has received prior hormonal/targeted therapy within 14 days prior to study registration
- More than two lines of chemotherapy or more than two lines of hormonal therapy excludes participation.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has known history of non-infectious pneumonitis/interstitial lung disease that required steroids or has any evidence of active pneumonitis/interstitial lung disease.
- Has known history of, or any evidence of active interstitial lung disease, Class II-IV congestive heart failure, or myocardial infarction within 6 months from randomization.
- 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.
- Breastfeeding during the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Has received a live vaccine or live-attenuated vaccine within 30 days of study registration. Administration of killed vaccines is allowed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Michigan State University, Breslin Cancer Center
Lansing, Michigan, 48910
University of Wisconsin
Madison, Wisconsin, 53705
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
New York University Clinical Cancer Center
New York, New York, 10016
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Read the detailed description
This is a non-randomized, multi-site, open-label Phase II trial for subjects with metastatic, hormone receptor positive, HER2 negative breast cancer. The study will enroll 47 patients to evaluate the anti-tumor activity of pembrolizumab with fulvestrant as measured by RECIST 1.1 tumor response and by progression free survival. We expect that if the immune response is augmented by the addition of pembrolizumab, significant change in durability of response will be noted.
Patients will be treated with pembrolizumab dosed at 200 mg intravenous infusion in combination with standard fulvestrant 500mg intramuscular injection.
- Conditions
- Breast Cancer
- Being tested
- Pembrolizumab, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200mg IV, 21 day cycles
FulvestrantDrug
Also called Faslodex
Fulvestrant, 500mg IM, Loading dose: C1 D1 \& 15. Thereafter, Q4 wks
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Fulvestrant | Experimental | Pembrolizumab 200m IV q3W + Fulvestrant. Loading dose 500mg IV IM q2W x3 followed by 500mg IM q4W Receives: Drug: Pembrolizumab; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Ratio (CBR)
Clinical benefit ratio (CBR) is defined as the percentage of patients that achieve CR, PR, or stable disease for a minimum of four months. Patients will be evaluated for response by RECIST 1.1 and irRECIST.
Measured: 36 months
Secondary outcomes (4)
Safety profile of pembrolizumab plus fulvestrant
To describe the toxicity profile of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. The toxicity profile will report all grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4
Measured: 36 months
Progression free survival (PFS)
Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause. PFS will be assessed by RECIST 1.1 and irRECIST
Measured: 36 months
Durable response rate (DRR)
Durable response rate is defined as the number of months that a stable disease, partial or complete response is observed.
Measured: 36 months
Overall Survival
Overall survival is defined as defined as the time from date of treatment start until death
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start29 Jan 2018
- Primary completion4 Aug 2023
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nancy Chan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Nancy Chan, MD, Big Ten Cancer Research Consortium
- Investigators
- Nancy Chan, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393845
- Sponsor's protocol ID
- BTCRC-BRE16-042
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2018
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042
- ClinicalTrials.gov ID
- NCT03393845
- Acronym / sponsor ID
- BTCRC-BRE16-042
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Nancy Chan, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Detailed description
This is a non-randomized, multi-site, open-label Phase II trial for subjects with metastatic, hormone receptor positive, HER2 negative breast cancer. The study will enroll 47 patients to evaluate the anti-tumor activity of pembrolizumab with fulvestrant as measured by RECIST 1.1 tumor response and by progression free survival. We expect that if the immune response is augmented by the addition of pembrolizumab, significant change in durability of response will be noted.
Patients will be treated with pembrolizumab dosed at 200 mg intravenous infusion in combination with standard fulvestrant 500mg intramuscular injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Fulvestrant | Experimental | Drug: Pembrolizumab, Drug: FulvestrantPembrolizumab 200m IV q3W + Fulvestrant. Loading dose 500mg IV IM q2W x3 followed by 500mg IM q4W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Men [29] and women ≥ 18 years of age at the time of informed consent. NOTE: Both pre- and post-menopausal women are eligible. Patients who are premenopausal should either undergo bilateral oophorectomy or receive ovarian suppression according to institutional standards. Male patients will be treated as premenopausal females and receive a GnRH agonist.
- ECOG Performance Status of 0 or 1 within 28 days prior to registration.
- Histologic or cytologic diagnosis of metastatic breast cancer.
Key exclusion criteria (20 listed)
- Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a known history of active TB (Bacillus Tuberculosis). NOTE: TB testing is not required.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). NOTE: HIV testing is not required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab 200mg IV, 21 day cycles | Drug | Pembrolizumab + Fulvestrant |
| FulvestrantAlso: FaslodexFulvestrant, 500mg IM, Loading dose: C1 D1 \& 15. Thereafter, Q4 wks | Drug | Pembrolizumab + Fulvestrant |
Primary outcome
Clinical Benefit Ratio (CBR)
Time frame: 36 months
Clinical benefit ratio (CBR) is defined as the percentage of patients that achieve CR, PR, or stable disease for a minimum of four months. Patients will be evaluated for response by RECIST 1.1 and irRECIST.
4 secondary outcomes
Safety profile of pembrolizumab plus fulvestrant
Time frame: 36 months
Progression free survival (PFS)
Time frame: 36 months
Durable response rate (DRR)
Time frame: 36 months
Overall Survival
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Chan principal investigator
Rutgers Cancer Institute of New Jersey
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Fulvestrant in people with Breast Cancer, run by Nancy Chan, MD at 5 sites in United States.
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 28 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Benefit Ratio (CBR) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.