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

Phase III Trial: Adding Immunotherapy to Chemotherapy for High-Risk Breast Cancer

NCT: NCT06058377 · Status: RECRUITING · Phase: Phase 3 · Sponsor: National Cancer Institute (NCI) · Started: 2023-11-27 · Est. Completion: 2026-05-31

Plain English Summary

Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer is a Phase 3 clinical trial sponsored by National Cancer Institute (NCI) studying Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma. This trial tests if adding an immunotherapy drug called durvalumab to standard chemotherapy (paclitaxel, cyclophosphamide, doxorubicin) can prevent breast cancer from returning in certain patients. It is for adults with hormone-receptor positive, HER2-negative breast cancer that is considered high-risk based on a test called MammaPrint. Participation involves receiving either the combination of durvalumab and chemotherapy or chemotherapy alone, and may include optional tissue and blood sample collection. Alternatives include standard chemotherapy regimens, other cancer treatments, or no further treatment, depending on the patient's specific situation and doctor's recommendation. The trial aims to enroll 3680 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with stage II or III hormone-receptor positive, HER2-negative breast cancer. Patients must have a MammaPrint score indicating 'High 2 Risk' and have not received prior treatment for their current breast cancer. Individuals with metastatic disease, locally recurrent breast cancer, or certain autoimmune conditions may not be eligible. This trial is studying Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome, Breast Cancer Event-Free Survival (BC-EFS), measures how long patients live without their breast cancer returning or progressing, up to 10 years after treatment. The specific primary outcome measures are: Breast cancer event-free survival (BC-EFS) (Up to 10 years after completion of study treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for more effective treatments for high-risk early-stage breast cancer, aiming to reduce the chances of the cancer returning by leveraging the body's immune system. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, where improved treatment options are needed.

Investor Insight

This trial targets a significant segment of the breast cancer market and explores a promising immunotherapy combination, suggesting potential for improved treatment outcomes and a competitive advantag Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 3680 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the MammaPrint test and what your score means for your treatment options. Discuss the potential benefits and risks of both durvalumab and standard chemotherapy with your healthcare team. Understand that participation involves regular clinic visits for treatment, monitoring, and potential sample collection. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines

  * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible
* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer

  * NOTE: Participants with inflammatory breast cancer are eligible
  * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node
* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines
* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer
* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions

  * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued
* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status

  * Submitting tissue for on-study MammaPrint testing:

    * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment

      * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR
  * Submitting prior known MammaPrint Index Score:

    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy

      * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network
      * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study
      * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment
* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy
* STEP 1: REGISTRATION (SCREENING): Participants must be \>= 18 years old at the time of registration
* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \> 30 kg
* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2
* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficien

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06058377?

NCT06058377 is a Phase 3 INTERVENTIONAL study titled "Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer." It is currently recruiting and is sponsored by National Cancer Institute (NCI). The trial targets enrollment of 3680 participants.

What conditions does NCT06058377 study?

This trial investigates treatments for Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma. The primary condition under study is Anatomic Stage II Breast Cancer AJCC v8.

What treatments are being tested in NCT06058377?

The interventions being studied include: Biospecimen Collection (PROCEDURE), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Durvalumab (BIOLOGICAL), Genetic Testing (OTHER). Undergo optional collection of tissue and/or blood

What does Phase 3 mean for NCT06058377?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06058377?

This trial is currently "Recruiting." It started on 2023-11-27. The estimated completion date is 2026-05-31.

Who is sponsoring NCT06058377?

NCT06058377 is sponsored by National Cancer Institute (NCI). The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06058377?

The trial aims to enroll 3680 participants. The trial is currently recruiting and accepting new participants.

How is NCT06058377 designed?

This is a interventional study, uses randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT06058377?

The primary outcome measures are: Breast cancer event-free survival (BC-EFS) (Up to 10 years after completion of study treatment). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06058377 being conducted?

This trial is being conducted at 20 sites, including Birmingham, Alabama; Anchorage, Alaska; Tucson, Arizona; Fort Smith, Arkansas and 16 more sites (United States).

Where can I find official information about NCT06058377?

The official record for NCT06058377 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06058377. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06058377 testing in simple terms?

This trial tests if adding an immunotherapy drug called durvalumab to standard chemotherapy (paclitaxel, cyclophosphamide, doxorubicin) can prevent breast cancer from returning in certain patients. It is for adults with hormone-receptor positive, HER2-negative breast cancer that is considered high-risk based on a test called MammaPrint.

Why is this trial significant?

This trial addresses a critical need for more effective treatments for high-risk early-stage breast cancer, aiming to reduce the chances of the cancer returning by leveraging the body's immune system. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06058377?

Common side effects of chemotherapy can include fatigue, nausea, hair loss, and increased risk of infection. Durvalumab, an immunotherapy, can cause immune-related side effects affecting various organs, such as lung inflammation (pneumonitis) or skin reactions. There is a risk that the cancer may not respond to treatment or may return despite treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06058377?

Ask your doctor about the MammaPrint test and what your score means for your treatment options. Discuss the potential benefits and risks of both durvalumab and standard chemotherapy with your healthcare team. Understand that participation involves regular clinic visits for treatment, monitoring, and potential sample collection. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06058377 signal from an investment perspective?

This trial targets a significant segment of the breast cancer market and explores a promising immunotherapy combination, suggesting potential for improved treatment outcomes and a competitive advantag This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves receiving either the combination of durvalumab and chemotherapy or chemotherapy alone, and may include optional tissue and blood sample collection. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.