Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
15/12/2015
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

BR9405

Study information

Scientific title

Prospective randomised evaluation of high-intensity chemotherapy with peripheral blood progenitor support in patients with high risk 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

1. High Dose Arm: Induction chemotherapy with single agent doxorubicin (adriamycin), treatment to be repeated every 3 weeks for four cycles. Induction chemotherapy to be followed by high dose chemotherapy, cyclophosphamide then cyclophosphamide and thiotepa, with stem cell support.

2. Conventional Arm: Induction chemotherapy with single agent doxorubicin, treatment to be repeated every 3 weeks for four cycles followed by conventional cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight cycles.

Intervention type

Drug

Phase

Not Applicable

Drug names

Doxorubicin (adriamycin), cyclophosphamide, thiotepa, methotrexate, 5-fluorouracil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1997

Overall trial end date

30/06/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged >18 years (usually <55 years).
2. Histologically proven operable stage II or IIIA breast cancer with an involvement of at least four lymph nodes
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
4. Confirmed normal haematological and biochemical parameters
5. Free from overt metastatic disease
6. No other malignancy, except basal cell carcinoma of the skin or in-situ carcinoma of the cervix
7. Fit to receive treatment

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1997

Recruitment end date

30/06/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Amgen Limited (UK)

Sponsor details

240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom

Sponsor type

Industry

Website

http://www.amgen.com

Funders

Funder type

Industry

Funder name

Amgen (UK)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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

15/12/2015: no publications found on PubMed.