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The PERSEPHONE trial : duration of trastuzumab with chemotherapy in women with HER2 positive early breast cancer. Changing the randomisation point to address potential barriers to recruitment
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Earl, H. M., Loi, S., Vallier, A. L., Hiller, L., Ogburn-Storey, E., Higgins, H. and Dunn, Janet A. (2011) The PERSEPHONE trial : duration of trastuzumab with chemotherapy in women with HER2 positive early breast cancer. Changing the randomisation point to address potential barriers to recruitment. Cancer Research, 71 (24). doi:10.1158/0008-5472.SABCS11-OT1-02-08
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Official URL: https://doi.org/https://doi.org/10.1158/0008-5472....
Abstract
Background
Persephone is a phase III randomised controlled trial comparing six months of trastuzumab (9 doses) to the standard 12 month duration (18 doses) in patients with HER2 positive early breast cancer in respect of disease free survival, safety and cost-effectiveness. The trial opened to recruitment in October 2007 but soon showed that meeting recruitment targets was challenging, reaching only 20–30 patients per month. A key issue seemed to be the mandatory requirement to randomise before patients started trastuzumab treatment. Successful accrual of patients in the PHARE trial, a Persephone sister study, run by the National Institute for Cancer, Paris had not incorporated this criteria.
Method: In September 2009, following accrual of 316 patients, this potential barrier to recruitment was addressed by a major protocol amendment which relaxed the eligibility criteria to allow randomisation of patients who had received up to 9 doses of trastuzumab.
Results: To date, 1334 patients have been randomised into PERSEPHONE. After the amendment, monthly recruitment increased to 40–50 patients and, more recently, to 60–70 patients. Of the 1018 patients recruited since September 2009, 450 (44%) patients had received at least 1 dose of trastuzumab pre-randomisation (see Table).
Retrospective collection of pre-randomisation trastuzumab dose and toxicity information has proved successful, allowing analyses of dose intensity, toxicity and compliance to be carried out on all patients.
Conclusion: Relaxing the eligibility criteria has considerably improved recruitment into the PERSEPHONE trial without compromising the important endpoints the trial sets out to assess.
| Item Type: | Journal Item | ||||
|---|---|---|---|---|---|
| Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | ||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Journal or Publication Title: | Cancer Research | ||||
| Publisher: | American Association for Cancer Research | ||||
| ISSN: | 0008-5472 | ||||
| Official Date: | 15 December 2011 | ||||
| Dates: |
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| Volume: | 71 | ||||
| Number: | 24 | ||||
| DOI: | 10.1158/0008-5472.SABCS11-OT1-02-08 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
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