Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
07/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2413_disease.shtml

Contact information

Type

Scientific

Primary contact

Ms Judith Bliss

ORCID ID

Contact details

Section of Epidemiology
The Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
+44 (0)20 8722 4040
abc-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002582

Protocol/serial number

G9437812

Study information

Scientific title

Acronym

ABC

Study hypothesis

To determine the value of adding cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression to prolonged tamoxifen in women with early breast cancer.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression and prolonged tamoxifen/tamoxifen

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main endpoint used for evaluation of treatment efficacy will be overall survival based on all cause mortality. Relapse-free survival, breast cancer mortality and cardiovascular mortality will also be compared. In a subset of patients there will be a detailed assessment of quality of life. Health economic consequences will also be determined. Ongoing biological predictors of therapeutic response studies, funded by CRUK and BCC.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1993

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All women with early invasive breast cancer requiring adjuvant systemic therapy are eligible for the trial providing they have:
1. Early (operable) breast cancer
2. Histological confirmation of invasive carcinoma
3. No previous malignancy (except carcinoma in situ [CIS] cervix or basal cell carcinoma)
4. Received no previous systemic treatment for their disease
5. Given consent and available for subsequent follow-up

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

6000

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1993

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Epidemiology
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom
+44 (0)20 7352 8133
abc-icrctsu@icr.ac.uk

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17405996
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22417870

Publication citations

  1. Results

    Ovarian ablation or suppression in premenopausal early breast cancer: results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial., J. Natl. Cancer Inst., 2007, 99, 7, 516-525, doi: 10.1093/jnci/djk109.

  2. Results

    Pinhel I, Hills M, Drury S, Salter J, Sumo G, A'Hern R, Bliss JM, Sestak I, Cuzick J, Barrett-Lee P, Harris A, Dowsett M, , ER and HER2 expression are positively correlated in HER2 non-overexpressing breast cancer., Breast Cancer Res., 2012, 14, 2, R46, doi: 10.1186/bcr3145.

Additional files

Editorial Notes