A Cancer Research UK randomised phase II trial of ATN-224 (copper binding agent) in combination with letrozole versus letrozole alone in post-menopausal women with recurrent, oestrogen and/or progesterone receptor positive breast cancer
- Conditions
- MedDRA version: 14.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)recurrent oestrogen and/or progesterone receptor positive breast cancer
- Registration Number
- EUCTR2006-004149-40-GB
- Lead Sponsor
- Cancer Research UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 111
1. Histologically proven oestrogen and/or progesterone receptor positive breast cancer as defined by standard laboratory criteria.
2. Recurrent disease after treatment with an anti-oestrogen.
3. Post-menopausal women as defined by one of the following:
•surgical or radiation-induced, bilateral oophorectomy at least 1 year in the past;
•in women with an intact uterus, no menstrual periods for 12 consecutive months with no other biological or physiological cause;
•age 55 years or older;
•or under 55 years with documented follicle-stimulating hormone levels consistent with post-menopausal range within the past 4 weeks.
4. Measurable disease as measured by X-ray, computerised tomography (CT) or MRI scan, with at least one lesion that can be followed for response. These measurements must be done within 4 weeks of the patient going on study [the interval between the last anti-cancer therapy and these measurements must be at least 4 weeks]. Clinical measurements must be done within 1 week of the patient going on study.
5. Life expectancy of at least 6 months.
6. World Health Organisation (WHO) performance status of 0 to 2
7. 18 years or over.
8. Written (signed and dated) informed consent, and be capable of co-operating with treatment and follow-up.
9. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week before the patient goes on study.
Lab Test Value required
Haemoglobin (Hb) =9.0 g/dl
Neutrophils =1.5 x 10(9)/L
Platelets =100 x 10(9)/L
Serum bilirubin =1.5 x upper limit of normal (ULN)
Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST)
= 2.5 x ULN, unless due to tumour in which case up to 5 x ULN is permissible
Creatinine clearance =50 ml/min (measured or calculated)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosureas and Mitomycin-C) before treatment.
2. Tumours which over-express the HER2 protein.
3. Prior treatment with an aromatase inhibitor.
4. Currently receiving treatment with a luteinizing hormone-releasing hormone (LH-RH) analogue.
5. Currently receiving treatment with any other investigational medicinal product.
6. Currently receiving chronic steroid therapy for concurrent illness or cancer. [Short-term steroid use for concurrent illness is allowed, eg for acute asthma].
7. History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ATN-224, omeprazole, or letrozole.
9. Receiving any other copper-binding drug during the study (eg penicillamine or trientine).
10. Use of copper- or zinc-containing vitamins or supplements during the study.
11. Toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
12. Clinically apparent brain metastases.
13. Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not recovered.
14. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
15. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
16. Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal 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 for the study].
17. Concurrent congestive heart failure or prior history of class III/IV cardiac disease (New York Heart Association [NYHA]).
18. Any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method