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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

TREATMENT

Phase

PHASE2

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

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincent's Hospital

Research sites nearby

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St Vincent's Hospital
Sydney, New South Wales, Australia

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Geometric mean suppression of proliferation marker Ki67	The geometric mean suppression of the centrally assessed proliferation marker Ki67, after two weeks of intervention, compared with baseline	After two weeks of intervention, compared with baseline

Secondary outcome

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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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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.