Many women after having been treated for breast cancer can suffer from menopausal symptoms, which can include vasomotor symptoms such as hot flushes (flashes), sleep disturbance, fatigue, mood swings, cognitive dysfunction ('brain fog'), muscle and joint aches and pains, skin dryness, loss of libido and genitourinary symptoms including vaginal dryness.

 

As it has been well established that for patients with ER positive breast cancer, reducing the exposure to oestrogen improves survival, use of menopausal hormone therapy (also known as HRT or MHT) which usually includes oestrogens and progestogens is expected to increase the chances of relapse of breast cancer. Therefore HRT is not considered advisable after diagnosis of breast cancer.

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However, there is an increasing recognition that some women may like to have the opportunity to carefully consider the balance between the potential improvement in quality of life they can expect by taking HRT, and the higher risk of relapse and death from breast cancer. If robust quantification of these risks and benefits is available, it would greatly facilitate decisions about taking HRT after breast cancer. However, such data are not currently available, especially for the newer body-identical HRT drugs, for individual stages and types of breast cancer, and current treatments.

 

Therefore, further research is urgently needed to quantify the risks and benefits of oestrogen supplementation (especially with body-identical versions) for patients who have had breast cancer. The best way to quantify the risks and benefits would be in a randomised clinical trial. We propose the MENO-ABC (MENopausal hormone therapy Outcomes After Breast Cancer) Trial. We recommend that participation in this study is made mandatory for any patient with breast cancer who are considering taking MHT/HRT.

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We propose that the trial design should include all patients treated for breast cancer for whom MHT is deemed potentially useful. All, patients would then be counselled regarding the known evidence about HRT after breast cancer.

 

If the clinician and the patient reach an equipoise, then patients would offered to participate and be randomly allocated to either take MHT or placebo - they will be included in the MENO-ABC-Ran part of the trial. 

 

If however the clinician and the patient do not reach an equipoise, so randomisation is an acceptable option. Such patients will be offered to be registered in the trial for regular monitoring, whether they decide to take HRT or not - this will be called MENO-ABC-Reg part of the trial.

 

Data collected would include patient demographics, clinico-pathological details of the breast cancer and its treatment, and menopausal symptoms and treatment received (hormone therapy and non-hormone treatment). Outcomes would include menopausal symptoms, breast cancer outcomes, and other health outcomes (e.g., osteoporosis cardiovascular, mental health, diabetes,).

 

At the end of the study, we should be able to:

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a) accurately estimate the risk of breast cancer relapse according to patient’s age, demographics, symptoms, tumour characteristics, and treatment received (cancer, non-cancer, details of MHT if given), using data from patients who were registered but not randomised, but decided either to take MHT or not.

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b) determine the relative benefits and risks of taking MHT compared with placebo from the outcomes of the randomised trial.

 

We believe such an approach is pragmatic and practically feasible.

 

Data about long-term morbidity (e.g., breast cancer relapse, thromboembolic disease, osteoporosis, endometrial cancer, cardiovascular disease, quality of life) and mortality (breast cancer mortality, overall survival) could be used to build a tool to support informed MHT treatment decisions.

 

We propose to call this study the MENO-ABC Study (MENopausal hormone therapy and Outcomes After Breast Cancer), and recommend that participation in this study is made mandatory for any patient with breast cancer who are considering taking  MHT. 

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We can expect that clinicians treating breast cancer would be reluctant to recommend their patients to take HRT and so might many women, for the fear of raising the risk of relapse and death. We believe that the rising awareness of menopausal symptoms in breast cancer patients, as well as the increasing recognition that patients should have autonomy to decide about the care they receive and the risk they take, may allow many clinician-patient pairs to have the equipose to allow randomisation to take HRT or not. Our trial design will also allow registration of those who do not reach an equipose so that their outcomes (QOL, breast cancer events, and mortality) can also be monitored 

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As the first step, we would like conduct a feasibility study of 300 patients who have menopausal symptoms to assess the proportion of patients and clinicians who may participate in the Randomisation and the Registration parts of the trial.

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Rough draft flow diagram