A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

Last updated: November 20, 2023
Sponsor: St Vincent's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Letrozole

Tamoxifen and Prometrium

Letrozole and Prometrium

Clinical Study ID

NCT03906669
ACTRN1261000928213
  • Ages > 18
  • Female

Study Summary

A phase II randomised, open label study of pre-operative endocrine therapy with & without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-) breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed ER+ and PR+ breast cancer (defined as ≥10% positive stainingcells)
  2. Histologically confirmed HER2-negative breast cancer (defined as IHC 0-1 and/orFISH/CISH <2.2)
  3. Tumour size ≥1 cm as measured by ultrasound and/or mammogram
  4. Ability to understand all patient information and informed-consent documents, writteninformed consent to participate in the trial, and to avail tissue and blood samplesfor research
  5. Aged 18 years or older

Exclusion

Exclusion Criteria:

  1. Women currently on hormone therapies, including hormone replacement therapy and oralcontraceptive pill
  2. Locally advanced/inoperable and inflammatory breast cancer
  3. Planned for a mastectomy (due to increased risk of venous thromboembolism)
  4. Clinical evidence of metastatic disease
  5. Patients treated with other preoperative systemic therapies
  6. Nut allergy (prometrium contains peanut oil)
  7. Prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clottingdisorder
  8. Women who are pregnant or breast-feeding

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: Letrozole
Phase: 2
Study Start date:
March 20, 2018
Estimated Completion Date:
April 30, 2024

Study Description

There is bidirectional interplay between the progesterone receptor (PR) and oestrogen receptor (ER) in human breast cancers. There is evidence for a reprogramming of ER chromatin binding sites with 470 genes differentially regulated by dual treatment with estrogen plus progestogen compared to estrogen alone in breast cancer cell lines. Functionally, there was an additive anti-cancer effect with the addition of natural progesterone to endocrine therapy in preclinical breast cancer models.

This is a phase II multi-site, randomised, open-label, three-arm, study in 200 postmenopausal women with early-stage ER+, PR+, HER2-negative breast cancer. Eligible patients will be randomised (1:1:1) to receive 14 days of intervention with either letrozole 2.5mg PO daily (arm 1), letrozole 2.5mg + prometrium 300mg PO daily (arm 2) or tamoxifen 20mg + prometrium 300mg PO daily (arm 3), between diagnosis of breast cancer and definitive surgery.

Connect with a study center

  • St Vincent's Hospital

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

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