Anatomic Stage IIIB Breast Cancer AJCC v8Phase 2NCT02971748
Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
A Phase 2 study testing Pembrolizumab in people with Anatomic Stage IIIB Breast Cancer AJCC v8 and Anatomic Stage IIIC Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Breast Inflammatory Carcinoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 31 Dec 2027
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is willing and able to provide written informed consent for the trial.
- Is a female or male and >/= 18 years of age
- Has histological confirmation of breast carcinoma.
- Has confirmed inflammatory breast cancer by using international consensus criteria:
- Onset: Rapid onset of breast erythema, edema and/or peau d'orange, and/or warm breast, with/without an underlying breast mass
- Duration: History of such findings no more than 6 months
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- Extent: Erythema occupying at least 1/3 of whole breast
- Pathology: Pathologic confirmation of invasive carcinoma
- Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery. pCR is defined as the current American Joint Committee on Cancer (AJCC) breast cancer staging.
- Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed.
- Has positive ER or PR status. ER or PR >/= 10%
- Has a performance status of 0-1 on the ECOG Performance Scale.
- Has adequate organ function as determined by the following laboratory values:
- ANC >/= 1,500 /mcL, Platelets >/=100,000 /mcL, Hgb >/= 9 g/dL, creatinine levels < 1.5 x ULN, Total bilirubin </= 1.5 x ULN, ALT and AST </= 2.5 x ULN
- Participants of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† from heterosexual activity; OR (2) use (or have their partner use) acceptable contraception during heterosexual activity.
- Acceptable methods of contraception are: Single method (one of the following is acceptable): (1) intrauterine device (IUD); (2) vasectomy of a female participant's male partner; (3) contraceptive rod implanted into the skin. Combination method (requires use of two of the following): (1) diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide); (2) cervical cap with spermicide (nulliparous women only); (3) contraceptive sponge (nulliparous women only); (4) male condom or female condom (cannot be used together); (5) hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection.
- Female participants will be considered of non-reproductive potential if they are either:
- postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.); OR (2) have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
- Male participants will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition).
- 11. Has negative serum or urine pregnancy test for subjects of childbearing potential within 10 days before first dose.
- 12. Have completed radiation (if candidate for post-mastectomy radiation) or plans to begin radiation and endocrine therapy within 28 days.
- 13. If the participant has already started hormonal blockade therapy after radiation as adjuvant therapy, the patient is eligible as long as the hormonal therapy was initiated no more than 6 months before the screening day and the participant can start the study drug within 4 weeks since the completion of screening.
Who cannot join
- Is currently participating in a study of an investigational anti-cancer agent.
- Has a diagnosis of immunodeficiency or any other form of immunosuppressive therapy.
- Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.
- Note: Participants with ≤ Grade 2 neuropathy, alopecia and general disorders and administration site conditions (per CTCAE version 4.0) are an exception to this criterion and may qualify for the study.
- Has a known history of prior malignancy with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy and has no evidence of recurrence over the last 1 year since completion of curative therapy.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators, inhaled steroid or local steroid injections to the skin would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.
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- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- 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, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known active Hepatitis B or Hepatitis C
- Have received a live vaccine within 30 days prior to the first dose of trial treatment.
- Gastrointestinal tract disease or defect or previous history of colitis.
- Has proven or suspected distant metastasis that involves occurrence of breast cancer outside of loco-regional breast and lymph nodes area.
- Participants requiring daily corticosteroids either via po or infusion
- Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy During or After Radiation in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy
This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the disease free survival (DFS) at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy.
II. To determine the safety and toxicity profile of primary inflammatory breast cancer (IBC) patients who received combination of pembrolizumab and hormone receptor blockade.
EXPLORATORY OBJECTIVES:
- To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC patients treated with pembrolizumab.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 24 months.
- Conditions
- Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
- Being tested
- Pembrolizumab
- Medical subject headings
- Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pembrolizumab) | Experimental | Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Receives: Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment.
Measured: From treatment initiation through last available follow-up (up to approximately 9 years)
Participants With Treatment-Related Adverse Events
Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0.
Measured: From first dose through 30 days after last dose (up to approximately 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start26 Jan 2017
- Primary completion10 Dec 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anatomic Stage IIIB Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bora Lim, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971748
- Sponsor's protocol ID
- 2016-0096
- Other IDs
- NCI-2018-01297, 2016-0096
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2016
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anti-PD-1 (Pembrolizumab) in Combination With Hormonal Therapy During or After Radiation in Patients With Hormone Receptor (HR)-Positive Localized Inflammatory Breast Cancer (IBC) Who Did Not Achieve a Pathological Complete Response (pCR) to Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02971748
- Acronym / sponsor ID
- 2016-0096
- Conditions
- Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body, who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed description
PRIMARY OBJECTIVES:
- To determine the disease free survival (DFS) at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy.
II. To determine the safety and toxicity profile of primary inflammatory breast cancer (IBC) patients who received combination of pembrolizumab and hormone receptor blockade.
EXPLORATORY OBJECTIVES:
- To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC patients treated with pembrolizumab.
OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pembrolizumab) | Experimental | Biological: PembrolizumabPatients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Is willing and able to provide written informed consent for the trial.
- Is a female or male and >/= 18 years of age
- Has histological confirmation of breast carcinoma.
- Has confirmed inflammatory breast cancer by using international consensus criteria:
- Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery. pCR is defined as the current American Joint Committee on Cancer (AJCC) breast cancer staging.
Key exclusion criteria (17 listed)
- Is currently participating in a study of an investigational anti-cancer agent.
- Has a diagnosis of immunodeficiency or any other form of immunosuppressive therapy.
- Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery.
- Has a known history of prior malignancy with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy and has no evidence of recurrence over the last 1 year since completion of curative therapy.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or immunosuppressive agents. Participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators, inhaled steroid or local steroid injections to the skin would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.
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: Keytruda, Lambrolizumab, MK-3475, SCH 900475Given IV | Biological | Treatment (pembrolizumab) |
Primary outcome
Disease Free Survival (DFS)
Time frame: From treatment initiation through last available follow-up (up to approximately 9 years)
Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment.
Participants With Treatment-Related Adverse Events
Time frame: From first dose through 30 days after last dose (up to approximately 25 months)
Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Bora Lim, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 in people with Anatomic Stage IIIB Breast Cancer AJCC v8 and Anatomic Stage IIIC Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site 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 22 inclusion and 17 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 11 Jun 2026. 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 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?
Yes. Results are posted in the registry (first posted 22 Jan 2026). 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?
Disease Free Survival (DFS) (time frame: From treatment initiation through last available follow-up (up to approximately 9 years)). The study lists 2 primary outcomes in all. 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 11 Jun 2026.