Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058377
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-09-27
Brief Title:
Adding an Immunotherapy Drug MEDI4736 Durvalumab to the Usual Chemotherapy Treatment Paclitaxel Cyclophosphamide and Doxorubicin for Stage II-III Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Ultrahigh MP2 stage II-III hormone receptor positive HER2 negative breast cancer Immunotherapy with monoclonal antibodies such as durvalumab may help the bodys 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 Ultrahigh 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
Detailed Description:
PRIMARY OBJECTIVE
I To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab
SECONDARY OBJECTIVES
I To compare pathologic complete response rates ypT0is ypN0 in participants randomized to standard of care chemotherapy alone versus vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
II To compare residual cancer burden distribution between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
III To compare distant relapse-free survival between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
IV To compare overall survival between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
V To compare the frequency and severity of toxicities between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab among those who initiate the assigned treatment
PRIMARY QUALITY OF LIFE QOL OBJECTIVES
I To compare the change in fatigue Patient Reported Outcomes Measurement Information System PROMIS Fatigue experienced by participants randomized to neoadjuvant durvalumab plus chemotherapy vs participants randomized to chemotherapy alone at completion of active treatment at 20 weeks from baseline
II To compare the change in global physical health PROMIS Global Health experienced by participants randomized to neoadjuvant durvalumab plus chemotherapy vs participants randomized to chemotherapy alone at completion of active treatment at 20 weeks from baseline
SECONDARY QOL OBJECTIVES
I To compare the change in fatigue and global physical health experienced by participants randomized to neoadjuvant durvalumab plus chemotherapy vs participants randomized to chemotherapy alone during treatment at 12 weeks from baseline
II To compare the changes in global physical health and fatigue subsequent to treatment at years 1 and 2 between the two randomized study arms
III To compare the changes in global mental health PROMIS Global Health during active treatment weeks 12 20 and subsequent to treatment at years 1 and 2 between the two randomized study arms
IV To compare the severity and frequency of treatment-related symptoms using Patient-Reported Outcomes Common Terminology Criteria for Adverse Events PRO-CTCAE items diarrhea nausea cough shortness of breath rash and musculoskeletal pain over time experienced by patients receiving neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE
STEP 1 Patients without a known MammaPrint Ultrahigh MP2 score undergo MammaPrint testing on a previously-collected tissue sample Patients with MP2 score proceed to STEP 2
STEP 2 Patients are randomized to 1 of 2 arms
ARM 1 Patients receive paclitaxel intravenously IV over 30-60 minutes 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 over 30 minutes on day 1 of each cycle Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity
ARM 2 Patients receive paclitaxel IV over 30-60 minutes on days 1 and 8 of each cycle and durvalumab IV over 60 minutes on day 1 of every other 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 over 30 minutes on day 1 of each cycle and durvalumab IV over 60 minutes on day 1 of every other cycle Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity
All 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 standard of care SOC surgery and undergo collection of blood samples prior to STEP 2 treatment after cycle one of chemotherapy and one month post-SOC surgery
After completion of study treatment patients are followed until death or 10 years whichever occurs first
I To compare breast cancer event-free survival between participants randomized to standard of care neoadjuvant chemotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab
SECONDARY OBJECTIVES
I To compare pathologic complete response rates ypT0is ypN0 in participants randomized to standard of care chemotherapy alone versus vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
II To compare residual cancer burden distribution between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
III To compare distant relapse-free survival between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
IV To compare overall survival between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab
V To compare the frequency and severity of toxicities between participants randomized to standard of care neoadjuvant chemotherapy vs standard of care neoadjuvant chemotherapy concurrent with durvalumab among those who initiate the assigned treatment
PRIMARY QUALITY OF LIFE QOL OBJECTIVES
I To compare the change in fatigue Patient Reported Outcomes Measurement Information System PROMIS Fatigue experienced by participants randomized to neoadjuvant durvalumab plus chemotherapy vs participants randomized to chemotherapy alone at completion of active treatment at 20 weeks from baseline
II To compare the change in global physical health PROMIS Global Health experienced by participants randomized to neoadjuvant durvalumab plus chemotherapy vs participants randomized to chemotherapy alone at completion of active treatment at 20 weeks from baseline
SECONDARY QOL OBJECTIVES
I To compare the change in fatigue and global physical health experienced by participants randomized to neoadjuvant durvalumab plus chemotherapy vs participants randomized to chemotherapy alone during treatment at 12 weeks from baseline
II To compare the changes in global physical health and fatigue subsequent to treatment at years 1 and 2 between the two randomized study arms
III To compare the changes in global mental health PROMIS Global Health during active treatment weeks 12 20 and subsequent to treatment at years 1 and 2 between the two randomized study arms
IV To compare the severity and frequency of treatment-related symptoms using Patient-Reported Outcomes Common Terminology Criteria for Adverse Events PRO-CTCAE items diarrhea nausea cough shortness of breath rash and musculoskeletal pain over time experienced by patients receiving neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE
STEP 1 Patients without a known MammaPrint Ultrahigh MP2 score undergo MammaPrint testing on a previously-collected tissue sample Patients with MP2 score proceed to STEP 2
STEP 2 Patients are randomized to 1 of 2 arms
ARM 1 Patients receive paclitaxel intravenously IV over 30-60 minutes 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 over 30 minutes on day 1 of each cycle Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity
ARM 2 Patients receive paclitaxel IV over 30-60 minutes on days 1 and 8 of each cycle and durvalumab IV over 60 minutes on day 1 of every other 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 over 30 minutes on day 1 of each cycle and durvalumab IV over 60 minutes on day 1 of every other cycle Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity
All 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 standard of care SOC surgery and undergo collection of blood samples prior to STEP 2 treatment after cycle one of chemotherapy and one month post-SOC surgery
After completion of study treatment patients are followed until death or 10 years whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04566 | REGISTRY | None | None |
| S2206 | OTHER | None | None |
| S2206 | OTHER | None | None |
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |