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Trial record 1 of 1 for:    NCT02954874
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Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT02954874
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer. 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.

Condition or disease Intervention/treatment Phase
Invasive Breast Carcinoma Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Triple-Negative Breast Carcinoma Other: Laboratory Biomarker Analysis Other: Patient Observation Biological: Pembrolizumab Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare invasive disease-free survival (IDFS) of patients with triple-negative (TNBC) or low estrogen receptor (ER)-positive and/or HER2 borderline breast cancer who have >= 1 cm residual invasive breast cancer and/or positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab) adjuvant therapy compared to no MK-3475 (pembrolizumab), in both the entire study population and also in the PD-L1 positive subset.

SECONDARY OBJECTIVES:

I. To compare the effects of MK-3475 (pembrolizumab) on overall survival (OS) and distant recurrence-free survival (DRFS) between the two randomized arms for the PD-L1 positive patients and then all patients.

II. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient population with or without radiation therapy.

BEHAVIORAL AND HEALTH OUTCOMES (BAHO) STUDY OBJECTIVES:

I. To examine the association between biomarkers of inflammation and quality of life and patient reported outcomes between the two groups during and at the end of therapy.

II. To examine the long-term and late effects of treatment on patient-reported outcomes.

ADDITIONAL OBJECTIVE:

I. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (OBSERVATION): Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, and every 6 months for 4 years, then annually for 5 years.

ARM II (PEMROLIZUMAB): Patients receive pembrolizumab intravenously (IV) over 30 minutes on days 1 and 22. Cycles repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity.

All patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment.

After completion of study treatment, patients are followed up to 10 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (observation)
Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment.
 Other: Laboratory Biomarker Analysis
Correlative studies

Other: Patient Observation
Undergo standard monitoring
Other Names:
  • Active Surveillance
  • deferred therapy
  • expectant management
  • Observation
  • Watchful Waiting

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • irradiated
  • Irradiation
  • RADIATION
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation
Experimental: Arm II (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on days 1 and 22. Cycles repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment.
 Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • irradiated
  • Irradiation
  • RADIATION
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation


Outcome Measures
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Primary Outcome Measures :
  1. Invasive disease-free survival (IDFS) [ Time Frame: From date of randomization to date of first invasive recurrence, second invasive primary cancer (breast or not), or death due to any cause, assessed up to 10 years ]
    The distributions of IDFS will be estimated using the Kaplan-Meier method, with 95% confidence intervals (CI) calculated using Greenwood's formula. Comparisons between the two treatment arms will be performed using the stratified log-rank test. The hazard ratios and 95% CIs will be based on the stratified Cox proportional hazard model with treatment as the only covariate. Secondary analyses of IDFS will be performed to describe consistency or divergence across subgroups. This will include a forest plot of treatment hazard ratios and associated 95% confidence intervals for each level of the stratification factors and major prognostic covariates (such as use of radiation therapy). The statistical significance of the interaction between treatment and each stratification factor or prognostic variable will be assessed.

  2. Severity of fatigue [ Time Frame: 55 weeks after randomization ]
    Measured by Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale. Will be compared between the two treatment groups by means of multiple linear regression with adjustment for the corresponding baseline measurement as well as whether or not the patient received radiation therapy which is known to be associated with post-treatment fatigue. No multiple comparisons adjustment will be employed since these outcomes evaluate the toxicity of the investigational drug. The clinical meaningfulness of each comparison will be considered.

  3. Physical function [ Time Frame: 55 weeks after randomization ]
    Reported by patients measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global physical health scale. Will be compared between the two treatment groups by means of multiple linear regression with adjustment for the corresponding baseline measurement as well as whether or not the patient received radiation therapy which is known to be associated with post-treatment fatigue. No multiple comparisons adjustment will be employed since these outcomes evaluate the toxicity of the investigational drug. The clinical meaningfulness of each comparison will be considered.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 10 years ]
    The distributions of OS will be estimated using the Kaplan-Meier method, with 95% CI calculated using Greenwood's formula. Comparisons between the two treatment arms will be performed using the stratified log-rank test. The hazard ratios and 95% CIs will be based on the stratified Cox proportional hazard model with treatment as the only covariate.

  2. Distant recurrence-free survival (DRFS) [ Time Frame: From date of randomization to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause, assessed up to 10 years ]
    The distributions of DRFS will be estimated using the Kaplan-Meier method, with 95% CI calculated using Greenwood's formula. Comparisons between the two treatment arms will be performed using the stratified log-rank test. The hazard ratios and 95% CIs will be based on the stratified Cox proportional hazard model with treatment as the only covariate.

  3. Incidence of adverse events [ Time Frame: Up to 10 years ]
    Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity analysis will be conducted in all patients receiving at least one dose of MK-3475 (pembrolizumab). The incidence of adverse events will be reported.

  4. Severity and frequency of treatment-related symptoms (diarrhea, nausea, rash, cough, and shortness of breath, musculoskeletal pain) over time of patients receiving pembrolizumab [ Time Frame: Up to 10 years ]
    Compared without treatment. The distributions of the corresponding Patient Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) items will be compared between the two treatment groups using a mixed ordinal logistic regression model for repeated measures. The model will also include the corresponding baseline measurement and time. Presence of treatment-by-time interaction will be tested for each of these endpoints. Similar analyses will be performed for disease related symptoms. The descriptive and graphical methods suggested in Basch, et. al. will be used to summarize the distributions of different symptoms by treatment group over time.

  5. Emotional function and disease-related symptoms in patients receiving pembrolizumab [ Time Frame: Up to 10 years ]
    Assessed by PROMIS global mental health scale score. Will be compared between the two treatment groups using a mixed model for repeated measures analysis with adjustment for the baseline score and time. Presence of treatment-by-time interaction will be investigated.

  6. Impact of treatment and treatment-related symptoms on physical function in patients without therapy [ Time Frame: 55 weeks after randomization ]
    Compared to patients receiving pembrolizumab. A multiple linear regression model will be performed with physical health scale score as an outcome and treatment and treatment related symptoms as covariates. Presence of treatment by each individual symptom item interactions will be investigated.

  7. Relationship between treatment-related symptoms and adherence to the study medication [ Time Frame: Up to 10 years ]
    Will be investigated among patients randomized to pembrolizumab treatment group by means of multiple logistic regression. Patients who have been on study therapy for 70% or more of their expected time on therapy will be considered adherent.

  8. Resolution of treatment-related symptoms in patients receiving pembrolizumab [ Time Frame: 18 months after randomization ]
    Compared to patients without treatment. A change in severity of the particular symptom will be compared between the two treatment groups by means of multiple linear regression with adjustment for the corresponding measurement at the 55 week assessment point.

  9. Long-term quality of life and symptoms between the two treatment groups [ Time Frame: Up to 60 months after randomization ]
    Mixed models for repeated measures analysis will be used with adjustment for scores at 18 months to examine changes in physical and emotional domain scores, fatigue and other persistent symptoms over the course

  10. Role of pro-inflammatory cytokines in the development of pembrolizumab associated symptoms [ Time Frame: Up to 55 weeks ]
    Specifically focused on treatment-associated fatigue. This will be compared to patients in the observation group.

  11. Single nucleotide polymorphisms (SNPs) in the promotor region of pro-inflammatory cytokine genes and the risk for development and severity of treatment-associated fatigue and other symptoms [ Time Frame: Up to 10 years ]
    The role of these SNPs in the persistence of long-term fatigue in all patients will also be explored using treatment assignment as a covariate.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • STEP 1 REGISTRATION

  • Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER-, PR- weakly positive, and HER2- equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy; patients who are HER2 positive by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines are ineligible; HER2-negative and HER2-equivocal cases as per ASCO CAP guidelines that do not receive HER2-targeted therapy are eligible; patients with weakly ER or PR positive disease, defined as ER and/or PR less than or equal to (=<) 5% by immunohistochemistry, are eligible if the treating physician considers the patient not eligible for adjuvant endocrine therapy; residual disease must be >= 1 cm in greatest dimension, and/or have positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) observed on pathologic exam

    • NOTE: If the ER and/or HER2 results are discordant between the initial, pre-chemotherapy, and post-chemotherapy surgical tissue, the receptor status of the residual disease has to be used to determine eligibility. IHC-positive isolated tumor cells in the lymph node (N0 [i+]) are not considered node-positive and these patients also must have >= 1 cm residual invasive cancer in the breast to be eligible.
  • Patients must not have metastatic disease (i.e., must be clinically M0; systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines); patients must not have locally recurrent disease

  • It is preferred that axillary lymph node sampling is performed after completion of neoadjuvant chemotherapy to allow more accurate assessment of pathologic response; patients must have a complete axillary lymph node dissection after neoadjuvant chemotherapy in the following situations (except for patients participating in the Alliance A11202 trial):

    • Patients had documented pathologic involvement of the axillary nodes (fine needle aspiration [FNA] or core biopsy) before neoadjuvant chemotherapy and had sentinel node biopsy after neoadjuvant chemotherapy with positive sentinel node(s)

    • Patient had documented pathologic involvement of the axillary nodes (FNA or core biopsy) before neoadjuvant chemotherapy and had only 1 sentinel lymph node removed after neoadjuvant chemotherapy

      • NOTE: Patients who undergo sentinel node biopsy before starting neoadjuvant treatment and do not undergo post neoadjuvant assessment of the axillary nodes or who have negative axillary nodes on post neoadjuvant assessment must have >= 1 cm residual invasive cancer in the breast after completion of neoadjuvant chemotherapy

  • Patients must have a minimum of five, available unstained formalin-fixed paraffin-embedded (FFPE) slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; (these will be submitted to a central laboratory to determine PD-L1 expression); the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide; local PD-L1 results, even if available, will not substitute for central testing

    • NOTE: Initial order for specimen kits should be placed at least two weeks prior to registering the first patient at each site
  • Patients must be offered the opportunity to participate in specimen banking
  • English-speaking patients must be willing to participate in the BAHO substudy
  • Patients must have had neoadjuvant chemotherapy followed by surgery; the choice of neoadjuvant chemotherapy is determined by the treating physician; we recommend following the NCCN treatment guidelines for TNBC; patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed
  • Patients may receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration (e.g. 8 cycles of capecitabine as in the CREATE-X trial) after completion of surgery at the discretion of the treating physician; co-enrollment to EA1131 is allowed, provided that patients complete or discontinue adjuvant chemotherapy prior to step registration; at the time of step 1 registration, patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed; patients that have received adjuvant chemotherapy (including via co-enrollment to EA1131) must be registered to screening within 35 days after final dose of adjuvant chemotherapy

  • Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines:

    • 90 days prior to screening registration for patients not receiving post-operative (adjuvant) chemotherapy OR
    • 270 days prior to step 1 screening registration for patients who have received post-operative (adjuvant) chemotherapy Positive margins are allowed only if the surgical team of the patient deems further resection impossible
  • Patients for whom radiation therapy (RT) to the affected breast or chest wall and regional nodal areas is clinically indicated as per NCCN treatment guidelines, should receive routine RT after randomization when possible, and receive MK-3475 (pembrolizumab) concurrent with RT, if randomized to the experimental arm; however, routine RT administered, or initiated, prior to registration is also allowed; MK-3475 (pembrolizumab) may be added to ongoing radiation, or started after its completion, if randomized to the experimental arm, provided there are no > grade 1 radiation-related skin toxicities and provided that no radiosensitizing chemotherapy is being administered; co-enrollment in the Alliance A221505 (NCT03414970) and A011202 (NCT01901094) trials or in the NSABP-B51 (NCT01872975) trial is allowed, but patients must not be planning to receive radiation therapy given on these trials concurrently with MK-3475 (pembrolizumab) treatment on S1418; whether or not patient will receive RT and the extent of intended RT must be specified at time of registration; NOTE: Patients who receive post-operative chemotherapy may receive radiation therapy before or after the chemotherapy; a short course of reduced dose chemotherapy or other agents concomitant with radiation for radiation sensitization is not considered to be adjuvant chemotherapy
  • Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
  • Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol; however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy
  • Patients must have Zubrod performance status =< 2
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within 2 years prior to registration
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); 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
  • Patients must not have received live vaccines within 30 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

  • Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration; patients who have completed curative therapy for HCV are eligible; patients with known human immunodeficiency virus (HIV) infection are eligible if they meet each of the following 3 criteria:

    • CD4 counts >= 350 mm^3
    • Serum HIV viral load of < 25,000 IU/ml and
    • Treated on a stable antiretroviral regimen
  • No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer; stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years
  • Patients must have complete history and physical examination within 28 days prior to registration
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • STEP 2 REGISTRATION
  • Patients must not be registered to step 2 until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 14 days of receiving the e-mail notification confirming submission was evaluable for PD-L1 status
  • Absolute neutrophil count (ANC) >= 1,500 microliter (mcL), obtained within 28 days prior to step 2 registration
  • Platelets >= 100,000/mcL, obtained within 28 days prior to step 2 registration
  • Hemoglobin >= 9 g/dL, obtained within 28 days prior to step 2 registration
  • A serum thyroid-stimulating hormone (TSH) and/or free T4 must be obtained within 28 days prior to step 2 registration to obtain a baseline value
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL), obtained within 28 days prior to step 2 registration
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x IULN, obtained within 28 days prior to step 2 registration
  • Alkaline phosphatase =< 2.5 x IULN, obtained within 28 days prior to step 2 registration
  • Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min, obtained within 28 days prior to step 2 registration
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 28 day prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or vasectomy; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing; women of childbearing potential must plan to have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required
  • Patients must not have an active infection requiring systemic therapy at the time of starting therapy
  • Site must verify that there is no known change in the step 1 eligibility since initial registration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954874


Locations
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Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lajos Pusztai Southwest Oncology Group
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02954874    
Other Study ID Numbers: NCI-2016-01595
NCI-2016-01595 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1418/BR006
s16-02231
S1418 ( Other Identifier: SWOG )
S1418 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: August 2019
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
 Breast Diseases
Skin Diseases
Carcinoma in Situ
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents