You may have read in the national or local press about the IBIS trial of tamoxifen to prevent breast cancer. The study has now finished recruiting patients but patients already in it will continue to complete their five years of tablets. The interim results from the study were published in 2002. This showed a 30% decrease in breast cancer in patients who were taking tamoxifen but there was actually an increase in death by all other causes in this group as well. This may have been due to the side effects of tamoxifen or may have been a statistical quirk. The trial will continue so that the long term effects will be learnt. However a new trial IBIS II has now started, similar to IBIS I but using a newer drug called Anastrozole (trade name Arimidex), see below. Unfortunately, (maybe fortunately), women who participated in IBIS I are not eligible for IBIS II, but you may have a relative or friend who is.
Eligibility Criteria for Entry
Recent Publication of American Study
What happens when I have finished my 5 years
IBIS
South- West Study Centre: Breast Care Centre, Frenchay Hospital, Bristol, BS16 1LE.
Principal Investigator: Mr. S.J. Cawthorn, Consultant Breast Surgeon,
Local IBIS Co-ordinator: Sally Pearce
Associate Investigators: Mr. Z. Rayter, Bristol Royal Infirmary, Bristol. BS2 8HW.
Mr. H. Umpleby, Mr. P. Maddox, Royal United Hospital, Bath. BA1 3NG.
Tel: 0117 9753809, Fx. 0117 9753767
March, 1998
Here is a summary of the research we are doing.
We are seeking women, with a family history of breast cancer, to volunteer to take part in a study to see if a drug called Tamoxifen can help prevent breast cancer. Tamoxifen has been widely used to treat breast cancer for many years. Now we want to see if it is effective in preventing the disease develop. We know that Tamoxifen does have some minor side effects, but we also know that these are only experienced by some women. We would not have been allowed to do this work if it was thought we were putting healthy women at unnecessary risk.
This is The International Breast Cancer Intervention Study. (IBIS) Women are asked to come every 6 months to the Family History clinic where we monitor any problems they may have. The study is for 5 years and involves taking a tablet (either Tamoxifen 20 mgs. or a placebo) every day. I don’t know which tablet is given to whom, and a mammogram is offered every 18 months.
There are 18 centres around the UK doing this study to date. It is hoped that 7,000 women will be entered over the next 2 years from the UK, other European Countries and Australasia. The South-west Centre is expected to find at least 750 volunteers from the South and West. So far more than 550 women have agreed to take part here, and the response has been good, but we are still looking for more to come forward.
Mr. Cawthorn also has a Family History Assessment Clinic to which women can be referred if they would be eligible for the Study but are too young or do not wish to take part, at present. This has to be a normal GP / Consultant referral.
Mr. Zen Rayter, Consultant Surgeon, Bristol Royal Infirmary, has arranged for IBIS to be included as part of his Family History Assessment Clinic.
Mr. H. Umpleby, and Mr. P. Maddox, Consultant Surgeons, Royal United Hospital, Bath, have also arranged for IBIS to be available as part of their Family History Assessment Clinics.
If you, or anyone else, would like to discuss this further, please ask them to contact me, and I’ll do my best to help.
Mrs. Ruth Illingworth. IBIS Co-ordinator, Frenchay Breast Care Centre - 0117 9753809
(IBIS Co-ord. Centre, PO Box 123, London, WC2A 3PX. Tel. 0171 269 3151) RI/3/98
Eligibility Criteria for Entry
Age 45-70, with one or more of the following:
2. Mother, Sister or Daughter who developed cancer in both breasts.
3. Two or more close blood relatives (Mother, Sisters, Daughters, Aunts or Grandmothers) who developed breast cancer.
4. Having no children and a Mother or Sister who developed breast cancer.
5. Having had a benign biopsy with proliferative disease and a Mother, Sister or Daughter who developed breast cancer.
6. Lobular Carcinoma in situ.
7. Atypical ductal or lobular hyperplasia diagnosed at biopsy.
Age 40-44, with one or more of the following:
2. Mother, Sister or Daughter who developed cancer in both breasts, with first cancer diagnosed at age 50 or younger.
3. Having no children and a Mother or Sister who developed breast cancer at age 40 or younger.
4. Having had a benign biopsy with proliferative disease and a Mother or Sister who developed breast cancer at age 40 or younger.
5. Lobular Carcinoma in situ.
6. Atypical ductal or lobular hyperplasia diagnosed at biopsy.
Age 35-39, with one or more of the following:
2. Mother or Sister who developed cancer in both breasts, with first cancer diagnosed at age 40 or younger.
3. Lobular Carcinoma in situ.
Exclusions
a) Pregnant or at pregnancy risk. Pre or peri-menoausal woman must use non-hormonal contraceptive during tamoxifen therapy.
b) A previous cancer, except in situ cervix or basal cell carcinoma of the skin.
c) Life expectancy of less than ten years, or other medical condition more serious than the risk of breast cancer.
d) Psychologically or physically unsuitable for 5 years tamoxifen/placebo therapy.
e) Current treatment with anti-coagulants.
f) A previous deep vein thrombosis or pulmonary embolus.
g) Current tamoxifen use.
Recent Publication of American Study
You may have heard in the media about the recent (6/4/98) early publication of an trial by the National Surgical Adjuvant Breast and Bowel Project in the USA. This was a similar trial to IBIS with 13,388 patients with a high risk of getting breast cancer through family history or an existing breast disorder, being given tamoxifen or a placebo for up to 4 years. The criteria were for entering the trial were slightly different to that of the IBIS trial and obviously it is a different population of people to the IBIS trial.
The results were published earlier than expected because the investigators felt that they had enough information already to show that tamoxifen does reduce the incidence of breast cancer in high risk patients. Their figures showed a 45% reduction in breast cancers in the tamoxifen group (85 cases as against 154 in the placebo group). On the other hand there was an increase in 3 other conditions in the women taking tamoxifen: There were 33 cases of endometrial cancer (cancer of the womb) in the tamoxifen group as against 14 in the placebo group, there were 17 cases of pulmonary embolus in the tamoxifen group as against 6 in the placebo group and there were 30 cases of deep vein thrombosis in the tamoxifen group as against 19 in the placebo group. However it did suggest that tamoxifen protects against osteoporosis in the same way as HRT as there were 47 cases of bone fracture in the tamoxifen group as against 71 in the placebo group.
What does all this mean for the IBIS trial and the women taking part in it? Well at the moment the controlling authorities feel that there is still a lot more to be learnt about tamoxifen as a preventative measure for breast cancer and want to carry on with the trial and recruit new patients. But obviously if you want to discuss the matter further please get in touch with your local co-ordinator
When you finish your 5 years of the study, you will be told at the clinic to stop taking the tablets. You don't need to tail them off at all and you may notice no difference at all (especially if you were taking the non-active tablet (placebo)), but you may notice that symptoms such as hot flushes improve.
You will have one more clinic appointment in one year i.e.6 years, and then if you are under 50 we will organise 18 monthly mammograms for you at Frenchay. If you are over 50 you will get the 3 yearly mammograms through the NHS national screening programme which all women are offered. We feel that this is adequate, but as you have been having 18 monthly mammograms through IBIS, we will offer you the facility to have another mammogram in between the NHS ones, to bring it up to 18 monthly.
Six years after you started taking the tablets, you can find out what tablets you have been taking, Tamoxifen or Placebo, and we will give you the details about that at the time.
