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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

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 patients with ER+ and PR+ breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

II

Trial Acronym

WinPro

More information

Trial Identifiers

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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

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.

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.

Ask your doctor if this trial could be right for you.

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RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.