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RecruitingLast updated: 2 February 2024

WinPro: This phase II trial is evaluating a combination of hormone treatments that may be useful for pre-surgery breast cancer treatmentAn open-label, randomized, window of opportunity study between diagnosis and definite surgery, to assess the effect of antiestrogen therapies, alone and in combination with microionized progesterone (prometrium) in patients with newly diagnosed ER+PR+ breast cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

WinPro

Clinical summary

Summary

Eligible patients will be randomised to one of three groups. Group 1 patients will receive letrozole and promethium; patients in Group 2 will receive tamoxifen and promethium; and Group 3 will receive letrozole alone. All assigned treatments will be administered daily for two weeks prior to surgery.

Conditions

This trial is treating people with ER+ and PR+ breast cancer

Eligibility

Inclusion

 

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

 

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.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Cancer Council of NSW & St Vincent's Hospital, Sydney

Scientific Title

An open-label, randomized, window of opportunity study between diagnosis and definite surgery, to assess the effect of antiestrogen therapies, alone and in combination with microionized progesterone (prometrium) in patients with newly diagnosed ER+PR+ breast cancer

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