Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Cyclophosphamide for Anatomic Stage II Breast Cancer AJCC v8

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.

Official registry: https://clinicaltrials.gov/study/NCT06058377 · National Cancer Institute (NCI) · enrollment listed as 3,680

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Cyclophosphamide, or Doxorubicin. The registry lists allocation as randomized. 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.

They plan to enroll about 3,680 people at 565 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: Biospecimen Collection, Cyclophosphamide, Doxorubicin, Durvalumab, Genetic Testing, Mammography, Paclitaxel, Quality-of-Life Assessment

Primary outcome (registry wording): Breast cancer event-free survival (BC-EFS)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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 must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

565 listed

+ 3 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06058377 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06058377?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06058377?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary