TerminatedPhase 2ACTRN12610000506099

A Single Arm Phase II Study of the Efficacy of Tamoxifen in Triple Negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) but Oestrogen Receptor Beta Positive Metastatic Breast Cancer

Women over 18 years with Triple Negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) but Oestrogen Receptor Beta Positive Metastatic Breast Cancer will be treated with Tamoxifen to assess the efficacy of this treatment


Sponsor

Australia and New Zealand Breast Cancer Trials Group

Enrollment

66 participants

Start Date

Mar 14, 2011

Study Type

Interventional

Conditions

Summary

This study looks at the effectiveness of the drug tamoxifen in treating breast cancer which is classified as triple negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) and oestrogen receptor beta positive, where the cancer has spread to distant sites (metastases). Who is it for? You can join this study if you are a woman with triple negative metastatic breast cancer that is oestrogen receptor beta positive and chemotherapy and/or radiotherapy is currently not considered appropriate. Prior to entering the study, a sample of metastatic tumour must be tested and confirmed to be oestrogen receptor beta positive. Trial details Some breast cancer cells contain receptors which the female hormone oestrogen binds to, causing the cancer to grow. The study aims to find out whether tamoxifen may be useful for treating metastatic breast cancer that contains the oestrogen beta receptor. Tamoxifen is an anti-oestrogen drug which is frequently used to treat breast cancers that contain the oestrogen alpha receptor but has not been used specifically to treat breast cancers that contain the oestrogen beta receptor. Participants will all receive one oral tablet (20mg) of tamoxifen daily, unless they suffer unacceptable side effects, or their breast cancer progresses.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether the drug tamoxifen can help women with a specific type of metastatic breast cancer that is triple negative but has a particular marker called oestrogen receptor beta. It is for women aged 18 and older whose cancer has spread and for whom chemotherapy or radiotherapy is not currently recommended.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To assess the efficacy of tamoxifen 20 mg (oral tablet) daily in triple negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) but oestrogen receptor beta positiv

To assess the efficacy of tamoxifen 20 mg (oral tablet) daily in triple negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) but oestrogen receptor beta positive metastatic breast cancer. Tamoxifen will be administered for duration of the trial (no set time limit - patients will continue to take tamoxifen until progression, withdrawal of consent or unacceptable toxicity).


Locations(1)

New Zealand

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ACTRN12610000506099