None listed
Conditions
Brief summary
Menopausal symptoms are common in women treated for early breast cancer. Hormone replacement therapy (HRT) is very effective at relieving menopausal symptoms, but we do not know if HRT is helpful or harmful for women who have had breast cancer. This trial will determine the effects of HRT in women who have been treated for early breast cancer. The trial aims to include 1300 women from around the world who will be treated with either HRT or the best non-hormonal alternative treatment while being closely monitored by their cancer specialists and gynaecologist.
Interventions
HRT treatment shall aim at relieving vasomotor symptoms, and at the same time be well tolerated. The trial aims that investigating the effects of medium potency estrogen replacement (with or without progestins) therapy as it is commonly given in the environment where the patient lives and the clinician work. If there is no specific preference, the following is recommended:
1. Women with an intact uterus
a) Last menstrual bleeding, whether natural or caused by treatment, within two years: Cyclic
HRT treatment shall aim at relieving vasomotor symptoms, and at the same time be well tolerated. The trial aims that investigating the effects of medium potency estrogen replacement (with or without progestins) therapy as it is commonly given in the environment where the patient lives and the clinician work. If there is no specific preference, the following is recommended: 1. Women with an intact uterus a) Last menstrual bleeding, whether natural or caused by treatment, within two years: Cyclic combined estrogen-progestin combination (medium potency estrogen combined with a progestin, according to due treatment practice). b) Last bleeding, two years or longer ago: Continuous combined estrogen-progestin combination ( medium potency estrogen combined with a progestin, according to due tratment practice). 2. Women who have been hysterectomised a) Medium potency estrogen only according to due treatment practice. The patient's gynecologist will serve as the patient's consultant concerning choice of HRT, dosage and duration of treatment
Sponsors
Regional Oncologic Centre, Sweden
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion and Exclusion Criteria- The study is directed only towards patients with climacteric symptoms, however, the degree of symptoms necessary for entering the trial is not specified in this protocol. Both perimenopausal and menopausal women are accepted into the trial.- The patient shall have been treated previously on one occasion for a breast cancer in stages cancer in situ to stage II of disease, but with four or fewer involved axillary nodes if nodal status and number of nodes investigated known. Stages are defined by UICC pTNM staging.- The patient shall be free from recurrences of breast cancer. It is recommended that the patient has a recent (within three months) mammogram.- Both hormonal receptor positive and negative patients are accepted into the study. Patients with unknown receptor status are also accepted. It is strongly recommended that the responsible clinician tries to find primary data for hormone receptor status and reports these on the study form.- All primary treatment shall be finished including cytotoxic therapy and radiotherapy. Adjuvant tamoxifen and toremifene treatment is however accepted. Patients who have previously been randomized into trials comparing the effects ofchemotherapy and castration in premenopausal women are not accepted into the trial. Patients who have previously been treated with HRT after their breast cancer diagnosis or who are on hormonal breast cancer treatments other than tamoxifen or toremifene cannot be randomized.- Patients who have been treated with HRT before their breast cancer diagnosis can be randomized into the trial to continue with HRT or to stop treatment. To be eligible, the women shall have stopped her previous HRT at the latest one month after diagnosis and have been without treatment for at least 3 months. The HRT to be recommended will be the one proposed for the hormonal treatment arm in this protocol.- The patient shall not have had any other cancer, including metachronous breast cancer (patients with synchronous breast cancer are however eligible, stage is judged by the tumour with the highest stage). Previous treatment for basalioma of the skin or cervical cancer in situ is however permitted. - The patient shall be without contraindications for hormonal treatment.- The patient shall be willing to participate in the trial.- The patient shall not have any other serious disease strongly limiting life expectancy and/or likelihood to comply with treatment.
Exclusion criteria
Exclusion criteria is above in the 'inclusion' criteria section.
Outcome results
None listed