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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.
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
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
| DRUG: Letrozole
|
EXPERIMENTAL: Letrozole and Prometrium
| DRUG: Letrozole and Prometrium
|
EXPERIMENTAL: Tamoxifen and Prometrium
| DRUG: Tamoxifen and Prometrium
|
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 |
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