Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000038493
Ethics application status
Approved
Date submitted
17/12/2003
Date registered
17/12/2003
Date last updated
19/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
HABITS
Hormonal replacement therapy after breast cancer diagnosis - is it safe?
Scientific title
Hormonal replacement therapy after breast cancer diagnosis - is it safe?
Protocol for randomized clinical study concerning hormonal replacement therapy (HRT) after previous radical breast cancer treatment
Secondary ID [1] 35 0
National Clinical Trials Registry: NCTR444
Universal Trial Number (UTN)
Trial acronym
IBCSG 17-98 / BIG 3-97 (HABITS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 40 0
Condition category
Condition code
Cancer 47 47 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1241 0
Treatment: Drugs
Comparator / control treatment
The patients randomized to follow-up only (no HRT) are not going to receive placebo, but should be advised about best available symptomatic treatment without hormones
Control group
Active

Outcomes
Primary outcome [1] 72 0
The aim of the present study is to investigate in women with radically treated in situ, stage I or early stage II breast cancer, if the use of hormone replacement therapy (HRT for menopausal symptoms) is safe concerning risk of breast cancer recurrence.
Timepoint [1] 72 0
Patients will be assessed by the clinician for progression of disease and side effects of treatment at biyearly visits during the first three years as a minimum and yearly thereafter for a minimum of 5 years.
Secondary outcome [1] 134 0
Secondary aims are to look at differences between the two study arms concerning quality of life and risk of
breast cancer death. After the main analyses, a study organisation will be built to decide if it is feasible and clinically meaningful to follow the two patient cohorts over a long time by means of record linkage and questionnaires concerning the cumulative incidence of myocardial infarction, cerebral stroke and fracture of the spine or hip. It is to be noted that the postulated study entails that most women will have a relatively short exposure to exogenous estrogens and the effect on cardiovascular events and osteoporosis will probably be small if any.
Timepoint [1] 134 0
Patients will be assessed by the clinician for progression of disease at biyearly visits during the first three years as a minimum and yearly thereafter for a minimum of 5 years.
Secondary outcome [2] 135 0
Health Questionnaires
Timepoint [2] 135 0
Completed by the patient at years 1 and 3.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria is above in the 'inclusion' criteria section.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by phone or fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/1997
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 67 0
Self funded/Unfunded
Name [1] 67 0
Australian New Zealand Breast Cancer Trials Group
Country [1] 67 0
Australia
Primary sponsor type
University
Name
Regional Oncologic Centre, Sweden
Address
to be confirmed
Country
Sweden
Secondary sponsor category [1] 52 0
Other Collaborative groups
Name [1] 52 0
International Breast Cancer Study Group
Address [1] 52 0
trial now complete. No further information will be added due to time constraints.
Country [1] 52 0
Australia
Secondary sponsor category [2] 53 0
Other Collaborative groups
Name [2] 53 0
The Australian New Zealand Breast Cancer Trials Group
Address [2] 53 0
trial now complete. No further information will be added due to time constraints.
Country [2] 53 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 375 0
Border Medical Oncology
Ethics committee address [1] 375 0
Ethics committee country [1] 375 0
Australia
Date submitted for ethics approval [1] 375 0
Approval date [1] 375 0
Ethics approval number [1] 375 0
Ethics committee name [2] 376 0
Geelong Hospital
Ethics committee address [2] 376 0
Ethics committee country [2] 376 0
Australia
Date submitted for ethics approval [2] 376 0
Approval date [2] 376 0
Ethics approval number [2] 376 0
Ethics committee name [3] 377 0
Mount Hospital
Ethics committee address [3] 377 0
Ethics committee country [3] 377 0
Australia
Date submitted for ethics approval [3] 377 0
Approval date [3] 377 0
Ethics approval number [3] 377 0
Ethics committee name [4] 378 0
Mater Hospital
Ethics committee address [4] 378 0
Ethics committee country [4] 378 0
Australia
Date submitted for ethics approval [4] 378 0
Approval date [4] 378 0
Ethics approval number [4] 378 0
Ethics committee name [5] 379 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [5] 379 0
Ethics committee country [5] 379 0
Australia
Date submitted for ethics approval [5] 379 0
Approval date [5] 379 0
Ethics approval number [5] 379 0
Ethics committee name [6] 380 0
Royal hospital for Women
Ethics committee address [6] 380 0
Ethics committee country [6] 380 0
Australia
Date submitted for ethics approval [6] 380 0
Approval date [6] 380 0
Ethics approval number [6] 380 0
Ethics committee name [7] 381 0
Royal Women’s Hospital Melbourne
Ethics committee address [7] 381 0
Ethics committee country [7] 381 0
Australia
Date submitted for ethics approval [7] 381 0
Approval date [7] 381 0
Ethics approval number [7] 381 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35959 0
Address 35959 0
Country 35959 0
Phone 35959 0
Fax 35959 0
Email 35959 0
Contact person for public queries
Name 10430 0
Administrative Officer, Data Management
Address 10430 0
ANZ BCTG Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre NSW 2310
Country 10430 0
Australia
Phone 10430 0
+61 2 4925 3068
Fax 10430 0
+ 61 2 4985 0141
Email 10430 0
[email protected]
Contact person for scientific queries
Name 1358 0
Professor John F Forbes
Address 1358 0
ANZ BCTG Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre NSW 2310
Country 1358 0
Australia
Phone 1358 0
+61 2 49 85 0113
Fax 1358 0
+61 2 49 60 1539
Email 1358 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.