High Dose Therapy in Poor-Risk Primary Breast Cancer

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN52623943
• Date of registration: 19/08/2002
• Primary sponsor: Amgen Limited (UK)
• Public title: High Dose Therapy in Poor-Risk Primary Breast Cancer N/A
• Date of first enrolment: Jan 1 1999
• Target sample size: Not provided at time of registration
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN52623943
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

United Kingdom

Contacts

• Name: - -

Key inclusion & exclusion criteria

Inclusion criteria: 1. Complete prior resection of tumour and axillary node clearance
2. Histologically proven T1-T4 primary breast cancer with at least four involved nodes in the axilla
3. Adequate local therapy as defined in the protocol
4. Aged <60 years
5. No previous malignancy or evidence of metastatic disease
6. Fit to receive treatment
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Breast cancer

Intervention(s)

1. Regimen A: Chemotherapy, 5-fluorouracil, epirubicin and cyclophosphamide (FEC), one 3 week cycle, then FEC repeated every 4 weeks for five cycles.

2. Regimen B: Chemotherapy, FEC one 3 week cycle, then FEC repeated every 4 weeks for five cycles followed by high dose therapy with cyclophosphamide, thiotepa and carboplatin and peripheral blood stem cell support.

Primary Outcome(s)

Not provided at time of registration

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

ICCG/10/92

Source(s) of Monetary Support

Amgen (UK)

Secondary Sponsor(s)

N/A