Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
18/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

B27

Study information

Scientific title

Multicentre Cancer Chemotherapy Group Randomised Trial of Adjuvant Chemotherapy for 'Early' Breast Cancer

Acronym

Study hypothesis

Not provided at time of registration

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

Hospitals

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

Following initial local therapy, surgery with or without radiotherapy, patients are randomised to one of 2 treatment arms:
1. Arm A: Tamoxifen 10 mg twice daily for 12 months.
2. Arm B: A total of eight cycles of multidrug chemotherapy. Cyclophosphamide, vincristine and 5-fluorouracil to be given on day 1 and cyclophosphamide, vincristine and methotrexate on day 8 of each 3 week cycle.
3. Arm C: Multidrug chemotherapy with vincristine, methotrexate, chlorambucil and 5-fluorouracil repeated every 3 weeks for 8 cycles.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tamoxifen, cyclophosphamide, vincristine, 5-fluorouracil, methotrexate, chlorambucil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged <70 years
2. Operable primary breast cancer with tumour <5 cm in greatest diameter
3. Histologically proven axillary nose involvement
4. Adequate renal and liver function
5. No prior history of other malignant disease
6. No previous chemotherapy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Action Cancer Belfast (UK)

Sponsor details

1 Marlborough Park
Belfast
BT9 6XS
United Kingdom
+44 (0)289 080 3344
abc@email.com

Sponsor type

Research organisation

Website

http://www.actioncancer.org

Funders

Funder type

Research organisation

Funder name

Action Cancer Belfast (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

18/01/2016: no publications found on PubMed.