Assessing an Oral SERD, DZD3969 in Patients With Advanced ER+HER2- Breast Cancer (MU-LAN1)

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 162
• Participant gender: Female

Summary

This study will treat patients with advanced ER+HER2- breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with this new drug. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as alone and in combination with Palbociclib

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 18 years or older;

• Patients with histologically or cytologically confirmed diagnosis of breast cancer with evidence of metastatic or locally advanced disease, not amendable to resection or radiation therapy with curative intent;

• ER positive and/or PgR positive of recurrent, metastatic and/or primary tumor tissue;

• Negativity of HER2 of recurrent, metastatic and or primary tumor tissue;

• Part B: Patients must have progressed on or after at least one line, but no more than 3 lines of endocrine therapy and no more than 2 lines of chemotherapy for locally advanced/metastatic disease. Prior treatment must have included CDK4/6 inhibitors.

Exclusion Criteria:

• Prior treatment with chemotherapy within 4 weeks before screening;

• Radiotherapy with a limited field for palliation within 1 week of the first dose of study treatment;

• Symptomatic and/or life-threatening visceral metastases, including diffuse lymphangitic carcinomatosis, bulky liver or pulmonary metastases;

• Part B: Treatment with fulvestrant within 90 days;

• Part C: Prior treatment with chemotherapy, immunotherapy, endocrine therapy or any investigational drugs.