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S2206: Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Status: Recruiting

This trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer
• stage II or III breast cancer
• have not received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy
• must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion criteria
Interventions:

Procedure: Biospecimen Collection, Drug: Cyclophosphamide, Drug: Doxorubicin, Biological: Durvalumab, Other: Genetic Testing, Procedure: Mammography, Drug: Paclitaxel, Other: Quality-of-Life Assessment

Conditions:

Cancer

Keywords:

Breast cancer, HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer

Study Contact: Kristen Nelson - knelso65@fairview.org
Principal Investigator: Puneet Cheema
Phase: PHASE3
IRB Number: MMCORC086
See this study on ClinicalTrials.gov

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