RECENTLY ACTIVATED ALLIANCE TRIALS

Alliance A012303: ShortStop-HER2: Shortened duration of adjuvant therapy in patients with early-stage HER2+ breast cancer who achieve pCR after neoadjuvant chemotherapy with HER2 blockade

Overview: This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.
Study Chair: Adrienne Waks, MD, Dana-Farber Cancer Institute
Activated: 7/25/2025 | To learn more about ShortStop-HER2, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06876714

Alliance A032303: GAIN-BCG: Gemcitabine Alternating with INtravesical BCG Randomized Against BCG Alone for Patients with Recurrent High Grade Non-Muscle Invasive Bladder Cancer

Overview: This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.
Study Chair: Eugene Pietzak, MD, Memorial Sloan Kettering Cancer Center
Activated: 6/5/2025 | To learn more about GAIN-BCG, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT07000084

Alliance A222301: High-dose prophylactic gabapentin (HOPE) to prevent opioid use for oral mucositis pain during head and neck chemoradiotherapy: A phase III clinical trial

Overview: This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region.
Study Chair: Anurag Singh, MD, Roswell Park Comprehensive Cancer Center
Activated: 6/5/2025 | To learn more about the trial, visit CT.gov or click here.
ClinicalTrials.gov Identifier: NCT06992427