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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.

PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Histologically confirmed ER+ and PR+ breast cancer (defined as ≥10% positive staining cells)
  • Histologically confirmed HER2-negative breast cancer (defined as IHC 0-1 and/or FISH/CISH <2.2)
  • Tumour size ≥1 cm as measured by ultrasound and/or mammogram
  • 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
  • Aged 18 years or older
  • Exclusion criteria

  • Women currently on hormone therapies, including hormone replacement therapy and oral contraceptive pill
  • Locally advanced/inoperable and inflammatory breast cancer
  • Planned for a mastectomy (due to increased risk of venous thromboembolism)
  • Clinical evidence of metastatic disease
  • Patients treated with other preoperative systemic therapies
  • Nut allergy (prometrium contains peanut oil)
  • Prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clotting disorder
  • Women who are pregnant or breast-feeding
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Female

    Things to know

    Study dates

    Study start: 2018-03-20

    Primary completion: 2024-04-01

    Study completion finish: 2024-04-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT03906669

    Intervention or treatment

    DRUG: Letrozole

    DRUG: Letrozole and Prometrium

    DRUG: Tamoxifen and Prometrium

    Conditions

    • Early-stage Breast Cancer
    • Hormone Receptor Positive Tumor
    Image related to Early-stage Breast Cancer
    • Condition: Early-stage Breast Cancer, Hormone Receptor Positive Tumor

    • DRUG: Letrozole and other drugs

    • Sydney, New South Wales, Australia

    • Sponsor: St Vincent's Hospital

    Find a site

    Closest Location:

    St Vincent's Hospital

    Research sites nearby

    Select from list below to view details:

    • St Vincent's Hospital

      Sydney, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: Letrozole
    • Letrozole 2.5mg PO daily for 14 days between diagnosis of breast cancer and definite surgery
    DRUG: Letrozole
    • PO daily for 14 days
    EXPERIMENTAL: Letrozole and Prometrium
    • Letrozole 2.5mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery
    DRUG: Letrozole and Prometrium
    • PO daily for 14 days
    EXPERIMENTAL: Tamoxifen and Prometrium
    • Tamoxifen 20mg PO daily and Prometrium 300mg PO daily for 14 days between diagnosis of breast cancer and definite surgery
    DRUG: Tamoxifen and Prometrium
    • PO daily for 14 days

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Geometric mean suppression of proliferation marker Ki67The geometric mean suppression of the centrally assessed proliferation marker Ki67, after two weeks of intervention, compared with baselineAfter two weeks of intervention, compared with baseline

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Safety and tolerability: number of participants with treatment-related adverse events as assessed by CTCAE v4.0Safety and tolerability of combination therapy (NCI-CTCAE v4.0)2 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: 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.

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