Premenopausal ER-positive, PgR-positive early breast cancer MedDRA version: 20.0 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: UTROGESTAN
Product Name: UTROGESTAN
Pharmaceutical Form: Capsule
INN or Proposed INN: Progesterone
CAS Number: 57-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women 16 years of age and above • New diagnosed histologically confirmed breast cancer • Premenopausal as defined by the following criteria: o gonadotrophin levels (luteinizing hormone and follicle stimulating hormone) and oestradiol levels within the local laboratory’s reference range for premenopausal females • Ability to provide menstrual cycle information • ER positive (Allred =3) • PgR positive (Allred =3) • HER2 negative (IHC 1+ or 2+ and HER2/CEP17 ratio of =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Inoperable breast cancer • Inflammatory tumours • Evidence of metastatic disease • Prior endocrine therapy or chemotherapy for breast cancer • Any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ) • Concomitant use (defined as use within 12 weeks prior to entry) of OCP or any other oestrogen-containing medication or supplement • History of thromboembolic disease • Known carrier of genetic defects predisposing to thromboembolic disorders • Any medical condition that would prevent the use of low molecular weight heparin for venous thromboembolism prophylaxis • Uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels • Evidence of bleeding diathesis • Evidence of uncontrolled active infection • Evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial • Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the response to treatment as measured by changes in the Ki67 proliferation index after 2 weeks of treatment in ER positive, PgR positive, HER2 negative breast cancer.;Secondary Objective: The secondary objectives in this study are: - To determine changes in the pro-aptoptic marker cleaved caspase 3 after 2 weeks of treatment - To determine changes in ER, PgR (steroid nuclear receptors), FoxA1 (pioneer factor), Cyclin D1 (ER regulated gene) and RANKL (putative PgR target gene) protein and mRNA expression after 2 weeks of treatment - To determine changes in circulating steroidogenic hormones after two weeks of treatment. - To determine the pharmacokinetics of tamoxifen and N-desmethyltamoxifen (DMT). - To establish the safety and tolerability of progesterone plus tamoxifen.;Primary end point(s): The primary outcome measure is the Ki67 proliferation index.;Timepoint(s) of evaluation of this end point: Samples will be taken at baseline and after 14(+4) days of treatment (ending the day before or the day of surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in the pro-aptoptic marker cleaved caspase 3 after 2 weeks of treatment. • Changes in ER, PgR (steroid nuclear receptors), FoxA1 (pioneer factor), Cyclin D1 (ER regulated gene) and RANKL (putative PgR target gene) protein and mRNA expression after two weeks of treatment. • Changes in circulating steroidogenic hormones after two weeks of treatment. • Pharmacokinetics of tamoxifen and N-desmethyltamoxifen (DMT). • Safety and tolerability of progesterone plus tamoxifen. ;Timepoint(s) of evaluation of this end point: Baseline and 14(+4) days of treatment | — |
Countries
United Kingdom
Contacts
Public ContactHelen Scott
CRUK Liverpool Cancer Trials Unit
Outcome results
None listed