Clinical trial · Interventional
Exemestane With or Without ATN-224 in Treating Postmenopausal Women With Recurrent or Advanced Breast Cancer
A Cancer Research UK Randomised Phase II Trial of ATN-224 (Copper Binding Agent) in Combination With Exemestane Versus Exemestane Alone in Post-menopausal Women With Recurrent or Advanced, Oestrogen and/or Progesterone Receptor Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn as the clinical development of ATN-224 was terminated by the drug company who was providing ATN-224 for the study
Summary
Brief summary (as posted)
RATIONALE: Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ATN-224 may stop the growth of breast cancer by blocking blood flow to the tumor. It is not yet known whether giving exemestane together with ATN-224 is more effective than giving exemestane alone in treating patients with recurrent or advanced breast cancer. PURPOSE: This randomized phase II trial is studying the side effects of exemestane given together with or without ATN-224 and to see how well it works in treating postmenopausal women with recurrent or advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exemestane | Drug | Exemestane | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| proteomic profiling | Genetic | — | UNRESOLVED |
| SOD1 inhibitor ATN-224 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival
- measure
- Safety
Secondary outcomes (10)
- measure
- Response rate (complete and partial response) overall and at 16 and 24 weeks
- measure
- Rate of stable disease for ≥ 16 and ≥ 24 weeks
- measure
- Response duration
- measure
- Clinical benefit rate (complete and partial response, stable disease) at 16 and 24 weeks
- measure
- Time (in days) taken after starting SOD1 inhibitor ATN-224 to achieve target serum ceruloplasmin level (5 to 15 mg/dl)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Recurrent disease after 2-3 years of adjuvant treatment with an anti-estrogen (documented by imaging techniques)
* Advanced disease that has recurred during or after anti-estrogen therapy
* Measurable or evaluable disease by conventional techniques, with ≥ 1 lesion that can be followed for response
* Bone metastases only are eligible provided they have ≥ 1 lytic lesion (not previously irradiated or planned for irradiation) that can be followed by X-ray or CT scanning
* Cutaneous skin metastases only are eligible provided the skin lesions are \> 10 mm and can be followed by good quality photography with a ruler included in the photograph
* No clinically apparent brain metastases
* Hormone receptor status must meet 1 of the following criteria:
* Estrogen receptor-positivity
* Score ≥ 3 on a scale (range of 0 to 8), or equivalent score from other grading methods, representing the intensity and percentage of positive-staining tumor cells by immunohistochemistry
* Greater than or equal to 5 fmol/mg protein by ligand binding assay or ELISA
* Progesterone receptor-positivity
* Score ≥ 3 on a scale (range of 0 to 8) or equivalent score from other grading methods, representing the intensity and percentage of positive-staining tumor cells by immunohistochemistry
* No HER-2 overexpression, defined as gene amplification by fluorescence in situ hybridization \[FISH\] OR 3+ overexpression by IHC)
PATIENT CHARACTERISTICS:
* Postmenopausal as defined by any of the following:
* Surgical or radiation-induced
* No menstrual periods for 12 consecutive months with no other biological or physiological cause in women with an intact uterus
* Age ≥ 55 years
* WHO performance status 0-2
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 9.0 g/dL
* ANC ≥ 1.5 x 10\^9/L
* Platelet count ≥100 x 10\^9/L
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and/or AST ≤ 2.5 times ULN (5 times ULN if due to tumor)
* Creatinine clearance ≥ 50 mL/min
* No history of malabsorption syndromes or other gastrointestinal disorders that may affect SOD1 inhibitor ATN-224 absorption, including any of the following:
* Bowel obstruction
* Celiac disease
* Sprue
* Cystic fibrosis
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD1 inhibitor ATN-224, omeprazole (or other proton pump inhibitor), or exemestane
* No non-malignant systemic disease including active uncontrolled infection
* No serologic positivity for hepatitis B, hepatitis C, or HIV
* No concurrent congestive heart failure
* No history of NYHA class III-IV cardiac disease
* No other concurrent malignancy, except adequately treated cone-biopsied carcinoma in situ of the uterine cervix, basal cell or squamous cell carcinoma of the skin
* Cancer survivors who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years, and are deemed at low risk for recurrence are eligible
* No other condition which, in the investigator's opinion, would not make the patient a good candidate for this study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from all prior therapy (alopecia allowed)
* At least 1 year since prior bilateral oophorectomy
* Prior adjuvant or neoadjuvant treatment with tamoxifen allowed
* Prior adjuvant therapy with a non-steroidal aromatase inhibitor allowed
* More than 4 weeks since prior immunotherapy or chemotherapy (6 weeks for nitrosoureas and mitomycin-C)
* More than 4 weeks since prior major thoracic and/or abdominal surgery
* More than 3 weeks since prior endocrine therapy
* More than 4 weeks since prior and no concurrent radiotherapy (except to control pain or prevent fracture)
* No prior exemestane
* Concurrent iron-containing vitamins or supplements are allowed
* No concurrent luteinizing hormone-releasing hormone analog
* No concurrent oral bisphosphonates (IV bisphosphonates allowed)
* No concurrent chronic steroid therapy for concurrent illness or cancer (short-term steroid use for concurrent illness allowed \[e.g., for acute asthma\])
* No concurrent copper- or zinc-containing vitamins or supplements
* No concurrent participation in another interventional clinical study (participation in an observational study allowed)
* No other concurrent copper-binding drug (e.g., penicillamine or trientine)
* No other concurrent anticancer therapy or investigational agentReferences
Publications (0)
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