Progesterone as an anticancer therapy in breast cancer

Phase 2

Recruiting

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12618000928213
• Lead Sponsor: St Vincent's Hospital, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-01
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Post-menopausal women defined by any one of the following criteria;
a) Amenorrhea >12 months at the time of diagnosis and an intact uterus, with FSH and estradiol in the postmenopausal ranges,
b) prior bilateral oophorectomy, and
c) FSH and estradiol levels within the postmenopausal range (as per local practice) in women aged <55years who have undergone hysterectomy.
2. Histologically confirmed ER+ and PR+ breast cancers (defined as >10% positive staining cells)
3. HER2/CEP17 ratio of <2 (as per the ASCO CAP guidelines)
4. Tumour size >1cm as measured by ultrasound and/or mammogram
5. Ability to understand all patient information and informed-consent documents, written informed consent to participate in the trial, and to avail tissue and blood samples for research

Exclusion Criteria

1. Women currently on hormone therapies
2. Locally advanced/inoperable and inflammatory breast cancer
3. Clinical evidence of metastatic disease
4. Patients treated with other preoperative systemic therapies
5. Nut allergy (prometrium contains peanut oil)
6. Prior history of uterine cancer, deep vein thrombosis or pulmonary embolism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This outcome is assessed by immunohistochemistry on the paired tumour samples, comparing pre treated tumour from diagnostic sample, and post-treated samples at surgery. The geometric mean suppression of the centrally assessed proliferation marker Ki67, after two weeks of treatment, compared with baseline. This will be obtained by comparing the mean difference in Ki67 staining between pre and post-treated samples in each treatment arm.[At time of definitive surgery, which follows 2 weeks of therapy.]

Secondary Outcome Measures

Name	Time	Method
Safety of combination therapy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.0).[At time of definitive surgery, which follows 2 weeks of therapy.];Tolerability of combination therapy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.0). [At time or surgery and at the post surgery follow up visit];Translational studies on potential biomarkers of response (Blood and tumour tissue)[These will be collected prior to and at the time of surgery.]