At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed ER+ and/or PR+ (hormone receptor positive) and HER2-negative breast cancer per ASCO/CAP guidelines
- ✓Clinical stage II or III breast cancer
- ✓No metastatic disease (clinically M0 or Mx)
- ✓No locally recurrent breast cancer
- ✕HER2-positive disease by ASCO/CAP guidelines
- ✕Occult primary breast cancer with axillary nodal involvement
- ✕Metastatic disease
- ✕Locally recurrent breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Trial Of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone For Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Biospecimen Collection, Cyclophosphamide, and 6 other interventions for Anatomic Stage II Breast Cancer AJCC v8 and 3 related conditions. Currently recruiting, targeting 3,680 participants across 541 sites in 2 countries.
Signals
Detailed Summary
This phase III 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. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.
Study Details
Timeline
Arms & Interventions
Patients without a known MP2 score undergo MammaPrint testing on a previously-collected tissue sample. Patients with MP2 score proceed to STEP 2
Patients receive paclitaxel IV on days 1 and 8 of each cycle. Treatment repeats every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin IV and cyclophosphamide IV on day 1 of each cycle. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo mammography during screening (STEP 1). Patients have the option to also undergo collection of tumor tissue during initial biopsy (STEP 1) and at SOC surgery and undergo collection of blood samples throughout the study.
Patients receive paclitaxel IV on days 1 and 8 of each cycle and durvalumab IV over 60 minutes on day 1 of cycles 1, 3, and 5. Treatment repeats every 14 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin IV and cyclophosphamide IV on day 1 of each cycle, and durvalumab IV over 60 minutes on day 1 of cycles 7 and 9. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo mammography during screening (STEP 1). Patients have the option to also undergo collection of tumor tissue during initial biopsy (STEP 1) and at SOC surgery and undergo collection of blood samples throughout the study.
Interventions
Undergo optional collection of tissue and/or blood
Given IV
Given IV
Given IV
Undergo MammaPrint testing
Undergo mammography
Given IV
Ancillary studies