18 and older, female only, with Breast Cancer. 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.
Progression-free SurvivalPrimary· Until disease progression of death from any cause, up to 3 years
Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Treatment (Exemestane)
4.3
2.0 – 6.5
Overall Response RateSecondary· Until disease progression or off treatment, assessed up to 1 year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Group
Value
95% CI
Treatment (Exemestane)
8.3
1.8 – 22.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected over a period of 5 years and 8 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Exemestane)
Serious: 4/36 (11%)
Deaths: 30/36
Serious adverse events (5 terms)
Reaction
System
Treatment (Exemestane)
Rectal hemorrhage
Gastrointestinal disorders
—
Disease progression
General disorders
—
Device related infection
Infections and infestations
—
Skin infection
Infections and infestations
—
Hypotension
Vascular disorders
—
Other adverse events (155 terms — click to expand)
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal women with stage IV breast cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT02820961 — Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer
· Phase 1
· completed
NCT02077933 — Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast
· Phase 1
· completed
NCT02007512 — Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
· Phase 2
· completed
NCT01938846 — BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Ad
· Phase 1
· completed
NCT03176238 — Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
· Phase 3
· completed
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 City of Hope Medical Center trials
Trials by the same sponsor.
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
· Phase 2
· not yet recruiting
NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy
· Phase 2
· not yet recruiting
NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment
· Phase 1
· not yet recruiting
NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o
· NA
· withdrawn
NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can
· NA
· not yet 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 City of Hope Medical Center
Last refreshed: 19 October 2020
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/NCT00810797.