H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, female only, with Breast Cancer or Hormone Receptor Positive Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0Primary· 6 months
Modified preoperative endocrine prognostic index (mPEPI) of 0. Total PEPI score assigned to each patient is the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage, Ki67 level, and estrogen receptor (ER) status of the surgical specimen. A hazard ratio (HR) in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points.
mPEPI score of 0 indicates a tumor size of 5 cm or less, negative lymph nodes, and Ki67 (proliferation index) of less than or equal to 2.7%. Drug combination will be determined t
Clinical Complete response: Palpable lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression.
Group
Value
95% CI
Safety Run In: Durvalumab + Aromatase Inhibitor
58.8
Clinical Partial Response (PR)Secondary· 6 months
Clinical Partial response: A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more.
Group
Value
95% CI
Safety Run In: Durvalumab + Aromatase Inhibitor
41.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first study drug administration to 90 days post last dose of study treatment. Study terminated prematurely, adverse events were collected for 20 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Safety Run In: Durvalumab + Aromatase Inhibitor
Serious: 2/17 (12%)
Deaths: 0/17
Serious adverse events (3 terms)
Reaction
System
Safety Run In: Durvalumab …
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Vomitting
Gastrointestinal disorders
—
Other adverse events (78 terms — click to expand)
Reaction
System
Safety Run In: Durvalumab …
Fatigue
General disorders
—
Arthralgia
Musculoskeletal and connective tissue disorders
—
Headache
Nervous system disorders
—
Hot flashes
Vascular disorders
—
Nausea
Gastrointestinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Anorexia
Metabolism and nutrition disorders
—
Breast pain
Reproductive system and breast disorders
—
Cough
Respiratory, thoracic and mediastinal disorders
—
Pain
General disorders
—
Bruising
Injury, poisoning and procedural complications
—
Dizziness
Nervous system disorders
—
Constipation
Gastrointestinal disorders
—
Hypothyroidism
Endocrine disorders
—
Alopecia
Skin and subcutaneous tissue disorders
—
Pruritus
Skin and subcutaneous tissue disorders
—
Edema limbs
General disorders
—
Non-cardiac chest pain
General disorders
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Myalgia
Musculoskeletal and connective tissue disorders
—
Pain in extremity
Musculoskeletal and connective tissue disorders
—
Fall
Injury, poisoning and procedural complications
—
Intraoperative breast injury
Injury, poisoning and procedural complications
—
Abdominal pain
Gastrointestinal disorders
—
Dry skin
Skin and subcutaneous tissue disorders
—
Rash maculo-papular
Skin and subcutaneous tissue disorders
—
Skin and subcutaneous tissue disorders - Other
Skin and subcutaneous tissue disorders
—
Hyperthyroidism
Endocrine disorders
—
Skin infection
Infections and infestations
—
Vertigo
Ear and labyrinth disorders
—
Allergic reaction
Immune system disorders
—
Chills
General disorders
—
Facial pain
General disorders
—
General disorders and administration site conditions - Other
This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma
· Phase 2
· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
· Phase 2
· not yet recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
NCT06148038 — CBD for Breast Cancer Primary Tumors
· Phase 1
· recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
· Phase 2
· recruiting
Other H. Lee Moffitt Cancer Center and Research Institute trials
Trials by the same sponsor.
NCT05041335 — Wet Heparinized Suction for Abdominal Cancer
· NA
· not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs
· NA
· recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors
· Phase 1
· recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
· Phase 2
· recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 31 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03874325.