Bladder

Adjuvant
Alliance 031501
Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally-advanced Urothelial Carcinoma (AMBASSADOR) versus Observation NCT03244384
  • Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract or Lymph Node + disease
  • Tissue available for central PD-L1 testing
  • Must fit Disease status requirements of the protocol
  • Surgery performed > 4 weeks but < 16 weeks prior to pre-registration
  • No active autoimmune disease or history of immune related diseases
  • No prior PD-1 or PDL-1 therapy
  • ECOG Status 0-2

Breast

Prevention
Alliance A011401

Breast Cancer Weight Loss Study (BWEL Study) Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer NCT02750826

  • BMI > 27kg/m2 documented within 56 days prior to registration. Most recent BMI must be used for eligibility
  • Self-reported ability to walk at least 2 blocks (at any pace)
  • Histologically confirmed invasive breast cancer and registration must occur within 14 months after the first diagnosis
  • No history of invasive breast cancer in 5 years prior to registration other than the current diagnosis (prior DCIS at any time is acceptable)
  • All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration
  • All subjects must have sentinel lymph node biopsy and/or axillary lymph node dissection
  • Must meet comorbid conditions of the protocol
  • ECOG Status 0 or 1
 
 Alliance A011502

Phase II Double-Blinded Placebo-Controlled Trial of Aspirin as Adjuvant Therapy for Node-Positive HER2 Negative Breast Cancer: The ABC Trial NCT02927249

  • The patient can be male or female, with any ER/PgR status
  • Patient must be enrolled within 18 months of diagnosis if ER/PgR negative or within 10 years if ER/Pgr positive
  • ECOG Status 0-2
  • No history of GI Bleeding requiring transfusion, stroke, MI, a-fib
  • No chronic daily use of steroids or anti-coagulants
  • No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

Adjuvant

NRG-BR003
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer NCT02488967

  • The tumor must be unilateral invasive adenocarcinoma of the breast on histological exam
  • Primary tumor must be pT1-3, pN0-3.  If pN0, tumor must be > 3.0cm.
  • The tumor must have been determined to be HER2-negative
  • The tumor must have been determined to be ER and PgR Negative. Patients with < 1% ER and PgR staining by IHC are considered negative
  • Patients must have undergone sentinel lymph node biopsy and/or axillary lymph node dissection

 

SWOG S1418/BR006

Phase III Randomized Trial to Evaluate the Efficacy Stage II-III And Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1cm Residual Invasive Cancer or Positive Lymph Nodes After Neoadjuvant Chemotherapy NCT029554874
  • Patients must have histologically confirmed ER-, PR-, and HER2 – breast cancer (Triple negative) and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy
  • Must not have metastatic or locally recurrent disease
  • 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 postoperative (adjuvant) chemotherapy OR
  • 270 days prior to screening registration for patients who have received post-operative adjuvant therapy
  • Must not have had prior immunotherapy with anti– PD-L1, anti-PD1, anti-CTLA4, or similar drugs
  • Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery, or other anti-cancer therapy except radiation while receiving treatment in this study
  • ECOG Status 0-2
  • No other invasive malignancy is allowed except for the following; adequately treated skin cancer, in-situ breast or cervical cancer, Stage I or II invasive cancer treated with curative intent without evidence of disease recurrence for at least 5 years

Colon/Rectal

Prevention
SWOG S0820
Stage 0-IIIA Double-Blind Placebo-Controlled Trial of Eflornithine andSuldinac to Prevent Recurrence of High-Risk Adenomas and Stage 0-III Second Primary Colorectal Cancers in Patients with Colon or Rectal Cancer Phase III-Preventing Adenomas of the Colon with PACES NCT01349881

  • History of Stage 0, I, II or III colon or rectal cancer within 180-456 days of primary resection
  • One year post-op colonoscopy showing no evidence of disease
  • ECOG Status 0-1
  • Must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration.
  • Must not have documented hx of gastric/duodenal ulcer within 12 months

Lung

Quality of Life
  
Alliance A221504
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opiod Receptor Antagonist in Advanced Non-Small Cell Carcinoma  NCT03087708
  • Advanced Stage IIIB or IV NSCLC
  • ​No known EGFR or EML4-ALK drier mutations
  • Started first-line systemic therapy of MD’s choice within 12 weeks prior to registration, or planning to initiate therapy within 4 weeks after registration.
  • No more than 7 days of prior use of mixed opioid agonist/opioid antagonists within 4 weeks before regostration
  • No methadone within 4 weeks prior to registration
  • Patient must have used opioid medication(s) for pain at some time in the 4 weeks prior to registration
  • ECOG Status 0-2