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| Name | Class |
|---|---|
| Breast Cancer Now | OTHER |
| CRUK Cambridge Institute | UNKNOWN |
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Four in 10 women diagnosed with breast cancer undergo mastectomy with or without breast reconstruction and less than half are satisfied with how they look unclothed. Breast conservation (removing the area with the lump only) can offer less extensive surgery and improved breast appearance, which can therefore increase well-being.
Intensity-modulated radiotherapy (IMRT) closely shapes the radiation beam to the cancer and is currently given after breast surgery. A new combination of IMRT followed by hormone treatment given before surgery, may increase the possibility of breast conservation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiotherapy (IMRT) | Radiation | Simultaneous integrated boost technique using IMRT: 48 Gray (Gy) and 40 Gy will treat tumour and breast tissue respectively, in 15 fractions over 3 weeks. | ||
| Endocrine therapy | Drug | Endocrine therapy will commence following completion of radiotherapy, and will continue for 20 weeks. | ||
| Breast conserving surgery | Procedure | Surgery carried out using local protocol following completion of endocrine therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients successfully completing neo-adjuvant IMRT and endocrine treatment followed by beast surgery, as per study protocol. | Successful completion of IMRT is defined as:
Successful completion of endocrine treatment is defined as:
Successful surgery is defined as:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03 | Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03 | 3 weeks |
| Mastectomy rate | Analysis will be descriptive, and in accordance to the statistical analysis plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory research will be carried out to identify possible molecular and radiological biomarkers of response | Exploratory investigation of potential biomarkers include:
Immune response (TILs) Tumour proliferation (Ki67, Geminin) DNA damage response and cell cycle checkpoint activation (including 53BP1, RAD51, ATM1, BRCA1, p53, p21 and p-chk-1) Tumour microenvironment (hypoxia) - Multiplexed single cell proteomics of both cellular suspensions (including whole blood) and intact tissues, to investigate the immune response and other novel markers Since the identification of new biomarkers correlating with disease activity and the efficacy or safety of treatment is rapidly evolving, the definitive list of biomarkers remains to be determined. However they will be detailed in an appropriate analysis plan prior to undertaking any sample analysis. |
Inclusion Criteria:
Exclusion Criteria:
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Women with invasive breast cancer for planned treatment with neo-adjuvant endocrine therapy, where radiotherapy may make breast conserving surgery easier.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Ingleson, BSc | Contact | 01223 349702 | victoria.ingleson@addenbrookes.nhs.uk | |
| Anne-Laure Vallier | Contact | 01223 348086 | anne-laure.vallier@addenbrookes.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Charlotte E Coles, MB ChB, MRCP, FRCR, PhD | University of Cambridge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust | Recruiting | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
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Tumour tissue samples, blood samples
| 6 months |
| Peri/post operative complications | Including:
| 9 months |
| Volume of residual tumour and response to treatment | There will be a central review (2 readers) of all primary surgery histopathology reports for the secondary endpoint of pathological complete response (pCR). The histopathology slides from the surgical resection will be requested for central assessment of residual disease for all cases where there has not been a pCR. The variables that will be recorded include residual invasive tumour size in two dimensions, residual invasive tumour cellularity, number of lymph node metastases and size of the largest metastasis. A representative tumour tissue block will be selected and requested from the laboratory. Sections from the block will be taken for staining with ER and Ki67 to allow calculation of the histological assessment of residual tumour burden, and cores taken as per the protocol. | 6 months |
| Late normal tissue toxicity, as assessed by: 1) clinicians | Clinician - post-radiotherapy questionnaire (with permission from IMPORT Trial Management Group and Dr Penny Hopwood) | Annually for 5 years |
| Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs) | Patient Reported Outcome Measure - Validated Breast-Q questionnaire | Annually for 5 years |
| Late normal tissue toxicity, as assessed by: 2) Patient Reported Outcome Measurements (PROMs) | Patient Reported Outcome Measure - EORTC IL1 Modified BRECON23 PROM questionnaire. | Annually for 5 years |
| 6 months post last patient recruited |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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