Clinical Trials

Title   SWOG 1418
Principal Investigator/ Physician   Carole Norden, MD
Protocol┬áNo.   SWOG 1418
Open Date   02/16/2018
Gender   Female
Cancer Site   Breast
Status   Open
Sponsor   SWOG
Contact Email   MCI Clinical Trials

Protocol: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Inclusion Criteria: Patients must have histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) or ER, PR, 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 must not have metastatic disease; 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; Patients must have a minimum of five, available unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node; the tumor tissue must be adequate for PD-L1 testing, which typically requires a minimum of 100 cancer cells per slide; Patients must be offered the opportunity to participate in specimen banking; Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer; 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 must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS; 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 RT after randomization when possible, and receive MK-3475 (pembrolizumab) concurrent with RT, if randomized to the experimental arm; however, RT administered, or initiated, prior to registration is also allowed; pembrolizumab may be added to ongoing radiation, or started after its completion, if randomized to the experimental arm, provided there are no > grade 2 radiation-related skin toxicities; patients who have not yet started radiation must specify at the time of screening registration whether or not they will receive RT and the extent of intended RT; 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; Patients must not have an active infection requiring systemic therapy; 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 must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to 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 7 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) 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; Site must verify that there is no known change in the step 1 eligibility since initial registration

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