Study Sponsor: Genentech/Hoffmann-La Roche
Study Drug Name: Atezolizumab (In Combination With Adjuvant* Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone)
* Adjuvant means given after primary treatment, like surgery to remove a tumor, or given in addition to another treatment in an attempt to destroy any remaining cancer cells.
Drug Class: Atezolizumab belongs to a class of drugs called monoclonal antibodies. A monoclonal antibody is a type of protein made in a lab and designed to bind to only one substance, in this case, cancer cells. They can be used alone or to carry drugs, toxins, or radioactive substances directly to the cancer cells.
Route of administration: All drugs being used in this study are given through an IV.
Duration of Study: For participants receiving the study drug, the treatment period is one year. For participants receiving chemotherapy without the study drug, the treatment period is five months.
Target Patient Cancer Type: patients with Stage II-III TNBC (Triple Negative Breast Cancer)
Key Inclusion Criteria:
- Stage II-III TNBC
- Completed either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- No more than 8 weeks (56 days) between breast surgery and beginning study medication
Key Exclusion Criteria:
- History of invasive breast cancer
- Previous treatment with any of the following:
- Systemic anti-cancer treatment, like chemotherapy or anti-HER2 therapy
- Treatment with anthracyclines or taxanes
- allogeneic stem cell or solid organ transplant
- Treatment with systemic immunosuppressive medications within 2 weeks of starting the study treatment
- Active or history of autoimmune disease or immune deficiency
- Major lung diseases like idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
Through the recently launched Advancing Inclusive ResearchⓇ Site Alliance, Genentech is collaborating with several clinical research centers around the U.S. that have expertise and demonstrated success in bringing urban and rural populations and patients of color (specifically Black and/or Hispanic/Latinx) into clinical research. Together we are exploring best practices in engaging and building trust with medically disenfranchised populations through co-creation, collaboration and community building. We aim to share learnings from this work more broadly across the healthcare ecosystem.
Genentech shares accountability in moving the healthcare system towards equity in partnership with HCPs, intra-industry and cross-industry peers, nonprofits, community-based organizations, government and most importantly, patients themselves.
This study looks at how safe and effective the study drug, atezolizumab, is when given with paclitaxel. To do this, they are comparing the treatment regimen with and without the study medication.
That means one group of participants will be given:
- the study drug in combination paclitaxel, an anti-cancer chemotherapy drug
- followed by another round of treatment with the study drug combined with either doxorubicin or epirubicin (your doctor will be able to choose which they think is best for you) which are chemotherapy drugs belonging to a group called anthracyclines, and cyclophosphamide which is an immunosuppressive drug that works to slow or stop the growth of cancer cells in your body.
The other group will receive:
- followed by doxorubicin or epirubicin (your doctor will be able to choose which they think is best for you) and cyclophosphamide
- This group will not receive any of the study medication
Full Protocol Title: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer (IMpassion030)
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