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RecruitingLast updated: 26 April 2024

Optima: This study is comparing the management of patients with breast cancer using test-directed assignment to chemotherapy with standard management (chemotherapy)Optimal personalised treatment of early breast cancer using multiparameter analysis

Clinical summary

Summary

Participants in this study would orginarily be treated with a combination of chemotherapy and endocrine therapy. This study seeks to advance the development of personalised medicine in breast cancer by using multi-parameter tests to identify those patients who are likely to benefit from chemotherapy and sparing those who are unlikely to benefit from chemotherapy treatment.

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm A (Control), participants will receive chemotherapy followed by endocrine therapy.

In Arm B (Experimental), participants will undergo testing to determine whether they would be likely to benefit from chemotherapy. Participants deemed likely to benefit will receive chemotherapy followed by endocrine therapy, while those deemed unlikely to benefit will receive endocrine therapy only. 

Conditions

This trial is treating patients with invasive breast cancer for which surgery has recently been completed or is planned

Cancer

Breast Cancers Breast

Age

People40+

Phase

Unknown

Trial Acronym

Optima

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • ISRCTN42400492; BCT2202; NC340

Trial sponsor

niversity College London

Scientific Title

Optimal personalised treatment of early breast cancer using multiparameter analysis

Eligibility

Inclusion

Current inclusion criteria as of 29/09/2015:
1. Female or male, age >= 40
2. Excised invasive breast cancer with local treatment either completed or planned according to trial guidelines.
3. ER positive (Allred score >=3 or H-score >=10 or >1% of tumour cells stained positive) as determined by the referring site (in a laboratory meeting NEQAS standards).
4. HER2 negative (IHC 0-1+, or ISH negative/non-amplified (ratio of HER2/chromosome 17 <2.00 and copy number <6)) as determined by the referring site (in a laboratory meeting NEQAS standards).
5. Axillary lymph node status:
5.1. 1-9 involved (macrometastases i.e. >2mm) OR
5.2. Node negative AND tumour size >= 30mm.
Nodes containing micrometastases (i.e. >0.2-2mm) or isolated tumour cell clusters (ITC) only (i.e. <=0.2mm) will be considered to be uninvolved.
6. Considered appropriate for adjuvant chemotherapy by treating physician.
7. Patient must be fit to receive chemotherapy and other trial-specified treatments with no concomitant medical, psychiatric or social problems that might interfere with informed consent, treatment compliance or follow up.
8. Bilateral cancers are permitted provided at least one tumour fulfils the entry criteria and none meet any of the exclusion criteria.
9. Multiple ipsilateral cancers are permitted provided at least one tumour fulfils the entry criteria and none meet any of the exclusion criteria.
10. Written informed consent for the study.

Exclusion

Current exclusion criteria as of 29/09/2015:
1. >=10 involved axillary nodes (as defined in the inclusion criteria) or involved internal mammary node.
2. ER negative OR HER2 positive/amplified (as determined by the referring site).
3. Metastatic disease.
4. Previous diagnosis of malignancy unless:
4.1. Managed by surgical treatment only and disease free for 10 years
4.2. Previous basal cell carcinoma of skin, cervical intraepithelial neoplasia or ductal carcinoma in situ (DCIS) of the breast treated with surgery only or previous diagnosis of lobular carcinoma in situ (LCIS).
5. The use of oestrogen replacement therapy (HRT) at the time of surgery. Patients who are taking HRT at the time of diagnosis are eligible provided the HRT is stopped before surgery.
6. Pre-surgical chemotherapy, endocrine therapy or radiotherapy for breast cancer. Treatment with endocrine agents known to be active in breast cancer including ovarian suppression is permitted provided this was completed >1 year prior to study entry.
7. Commencement of adjuvant treatment prior to trial entry. Short-term endocrine therapy initiated because of, for instance, prolonged recovery from surgery is permitted but must be discontinued at trial entry.
8. Trial entry more than 8 weeks after completion of breast cancer surgery.
9. Planned further surgery for breast cancer, including axillary surgery, to take place after randomisation, except either re-excision or completion mastectomy for close or positive/involved margins which may be undertaken following completion of chemotherapy.
10. Patients with more than two involved axillary nodes (as defined in the inclusion criteria) identified by sentinel node biopsy or by axillary sampling where further axillary surgery is not planned.

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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