Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT02889874

Attivo, non recluta

EXPERT: EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer

Interventistico

Fase non elencata

Westmead Hospital

Sponsor: Breast Cancer Trials, Australia and New Zealand

Ultimo Aggiornamento: 9 aprile 2024
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Radioterapia

Mutazioni richieste

Studio Iniziato

21 agosto 2017

Ultimo Aggiornamento dello Sponsor

9 aprile 2024

Completamento Stimato

1 ottobre 2025

Contatto dello studio

Nome:Heath Badger

Email:expert@bctrials.org.au

Telefono:+61 2 4925 3022

Nome:Akiko Fong

Email:expert@bctrials.org.au

Telefono:+61 2 4925 3022

Idoneità

Criteri di Inclusione

1. Female patients aged ≥ 50 years of any menopausal status.

2. Primary tumour characteristics as assessed by conventional histopathology:

+ Unifocal histologically confirmed invasive breast carcinoma

+ Maximum microscopic size ≤2 cm

+ Grade 1 or 2 histology

+ ER and PR positive in ≥10% of tumour cells in either the biopsy or breast conserving surgical specimen

+ HER2 negative on IHC (score 0 or 1+) or in situ hybridisation (ERBB2-amplification Ratio ERBB2/centromeres <2.0 or mean gene copy number <6). Equivocal IHC score (2+) must be assessed by ISH.

3. Primary tumour must be resected by breast conserving surgery with microscopically negative margins for invasive carcinoma and any associated ductal carcinoma in situ (no cancer cells adjacent to any inked edge/surface of specimen) or re-excision showing no residual disease.

4. Histologically confirmed negative nodal status determined by sentinel node biopsy or axillary dissection. Patients with pN0 (i+) disease are eligible for study participation (malignant cells ≤0.2 mm in regional lymph node(s) detected by hematoxylin-eosin (H&E) stain or IHC, including isolated tumour cells).

5. No evidence of distant metastasis.

6. Eligible for and willing to have adjuvant endocrine therapy.

7. ECOG performance status 0-2.

8. Availability of FFPE tumour block for Prosigna (PAM50) Assay.

For randomization to the study, patients must fulfill all of the following criteria:

1. Primary tumour characteristics as assessed by Prosigna (PAM50) Assay:

* Luminal A intrinsic subtype

* ROR score ≤60

Criteri di Esclusione

Any one of the following is regarded as a criterion for exclusion from the study:

1. Primary tumour characteristics:

+ Presence of multifocal or multicentric invasive carcinoma or ductal carcinoma in situ;

+ Evidence of clinical or pathologic T4 disease (extension to the chest wall, oedema or ulceration of skin, satellite skin nodules, inflammatory carcinoma);

+ The invasive component of the primary tumour is present as micro-invasion only;

+ Grade 3 histology;

+ Presence of lymphovascular invasion

2. Contra-indication or unwillingness to have adjuvant endocrine therapy.

3. Planned to receive adjuvant chemotherapy or biologic therapy after breast cancer surgery, i.e. any systemic therapy other than endocrine therapy is not permitted. Any therapy unrelated to cancer is permitted at the discretion of investigators.

4. Treated with neoadjuvant endocrine therapy, chemotherapy or biologic therapy prior to breast cancer surgery.

5. Prior breast or thoracic RT for any condition.

6. Pre-operative breast imaging evidence of disease aside from the primary carcinoma resected by breast conserving surgery.

7. Concurrent invasive breast carcinoma or ductal carcinoma in situ (synchronous or metachronous).

8. Prior diagnosis of invasive breast carcinoma or ductal carcinoma in situ in either breast irrespective of disease free interval.

9. A diagnosis of non-breast malignancy <5 years prior to randomisation with the following exceptions:

+ Patients who are diagnosed with carcinoma in situ of cervix, endometrium or colon; melanoma in situ; and basal or squamous cell carcinoma of the skin at any time prior to randomisation are not excluded from study participation.

+ Patients who are diagnosed with other non-breast malignancy ≥5 years prior to randomisation and without evidence of disease recurrence are not excluded from study participation.

10. Significant comorbidity precluding definitive RT for breast cancer (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).

11. Life expectancy <10 years.

12. Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer.

13. Pregnant or lactating patients.

14. Inability to be registered to the study ≤8 weeks after the last surgical procedure for breast cancer.

15. Inability to commence RT (if randomised to receive RT) no later than 12 weeks from the last surgical procedure for breast cancer.

16. Inability to provide written informed consent.

17. Psychiatric, addictive, or any disorder that precludes compliance with protocol requirements.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare1167

Bracci e Interventi

Bracci

Interventi

Tipo: No Intervention

Descrizione: Patients randomized to Arm A will receive standard radiation therapy and adjuvant endocrine therapy (standard of care).

Interventi:

Omission of radiation therapy

Misure di Esito

Misure di Esito Primarie

Local recurrence rate after breast conserving surgery10 years

The time from randomisation to the date of local recurrence (LR) as a site of first recurrence.

Misure di Esito Secondarie

Local-regional recurrence-free interval (LRRFI)10 years

Time from randomisation to the date of local or regional recurrence as a site of first recurrence.

Distant recurrence-free interval (DRFI)10 years

Time from randomisation to the date of distant recurrence, regardless of occurrence of any intervening local or regional recurrence, contralateral breast cancer or second (non-breast) primary invasive cancer.

Disease free survival including DCIS (DFS-DCIS)10 years

Time from randomisation to date of first evidence of local (invasive breast carcinoma or DCIS), regional or distanct recurrence; contralateral breast cancer (invasive breast carcinoma or DCIS); second (non-breast) primary invasive cancer; or death.

Invasive disease free survival (iDFS)10 years

Time from randomisation to date of first evidence of local (invasive breast carcinoma), regional or distanct recurrence; contralateral breast cancer (invasive breast carcinoma); second (non-breast) primary invasive cancer; or death.

Recurrence-free interval10 years

Time from randomisation to the date of local, regional or distant recurrence as a site of first recurrence.

Overall survival (OS)10 years

Time from randomisation to date of death from any cause.

Salvage RT or mastectomy rate10 years

Time from randomisation to the receipt of salvage RT or mastectomy, individually and in combination (one or the other) as a composite endpoint.

Adverse events for patients5 years

Adverse events during treatment (up to 5 years of endocrine therapy) assessed using NCI CTCAE v4.0.

Assessment of the impact of endocrine therapy5 years

FACT-ES measure of endocrine symptoms.

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Siti dello Studio

Questo studio ha 68 siti

Westmead Hospital

Westmead, New South Wales, AU

Nome:Verity Ahern, A/Prof

In fase di reclutamento

Westmead, New South Wales, 2145 AU

Westmead Hospital

In fase di reclutamento

Box Hill, Victoria, 3128 AU

Box Hill Hospital

In fase di reclutamento

Randwick, New South Wales, 2031 AU

Prince of Wales Hospital

In fase di reclutamento

Nedlands, Western Australia, 6009 AU

Sir Charles Gairdner Hospital

In fase di reclutamento

Port Macquarie, New South Wales, 2444 AU

Port Macquarie Base Hospital

In fase di reclutamento

Heidelberg, Victoria, 3084 AU

Austin Hospital

In fase di reclutamento

Woolloongabba, Queensland, 4102 AU

Princess Alexandra Hospital

In fase di reclutamento

Taipei, 100 TW

National Taiwan University Hospital

In fase di reclutamento

Liverpool, New South Wales, 1871 AU

Liverpool Hospital

In fase di reclutamento

Newcastle, New South Wales, 2298 AU

Calvary Mater Newcastle

In fase di reclutamento

Melbourne, Victoria, 8006 AU

Peter MacCallum Cancer Centre

In fase di reclutamento

Gosford, New South Wales, 2250 AU

Gosford Hospital

In fase di reclutamento

Wellington, 6021 NZ

Wellington Hospital

In fase di reclutamento

Hamilton, 3240 NZ

Waikato Hospital

In fase di reclutamento

Changhua, 500 TW

Changhua Christian Hospital

In fase di reclutamento

Galway, IE

University Hospital Galway

In fase di reclutamento

Christchurch, 8011 NZ

Christchurch Hospital

In fase di reclutamento

Barcelona, Barcelona, 8035 ES

Hospital Universitario Valle de Hebrón

In fase di reclutamento

Taipei, 10449 TW

Mackay Memorial Hospital

In fase di reclutamento

Canberra, Australian Capital Territory, 2605 AU

The Canberra Hospital

In fase di reclutamento

Tainan, 704 TW

National Cheng Kung University Hospital

In fase di reclutamento

Taipei, 114 TW

Tri-Service General Hospital

In fase di reclutamento

Fitzroy, Victoria, 3065 AU

St Vincent's Hospital Melbourne

In fase di reclutamento

Campbelltown, New South Wales, 2560 AU

Macarthur Cancer Therapy Centre

In fase di reclutamento

Taipei, 11217 TW

Taipei Veterans General Hospital

In fase di reclutamento

Milan, IT

Istituto Europeo di Oncologia

Non ancora in reclutamento

Locarno, Ticino, 6600 CH

FOLM - Fondazione Oncologia Lago Maggiore

In fase di reclutamento

Barcelona, Barcelona, 8036 ES

Hospital Clínic de Barcelona

In fase di reclutamento

Palmerston North, 4414 NZ

Palmerston North Hospital

In fase di reclutamento

Santa Fe, AR

Instituto de Oncologia de Rosario

In fase di reclutamento

Kaohsiung, TW

Kaohsiung Medical University Hospital

In fase di reclutamento

North Sydney, New South Wales, 2060 AU

Mater Hospital Sydney

In fase di reclutamento

Camperdown, New South Wales, 2050 AU

The Chris O'Brien Lifehouse

In fase di reclutamento

Darlinghurst, New South Wales, 2010 AU

St Vincent's Hospital, Sydney

In fase di reclutamento

Gateshead, New South Wales, 2290 AU

Genesis Cancer Care Newcastle

In fase di reclutamento

Tamworth;, New South Wales, 2340 AU

Tamworth Rural Referral Hospital

In fase di reclutamento

Wollongong, New South Wales, 2500 AU

Wollongong Hospital

In fase di reclutamento

Auchenflower, Queensland, 4066 AU

Genesis Cancer Care Wesley

In fase di reclutamento

Kurralta Park, South Australia, 5037 AU

GenesisCare Tennyson

In fase di reclutamento

Ballarat, Victoria, 3353 AU

Ballarat Austin Radiation Oncology Centre

In fase di reclutamento

Bendigo, Victoria, 3550 AU

Peter MacCallum Cancer Centre - Bendigo

In fase di reclutamento

Bentleigh East, Victoria, 3165 AU

Peter MacCallum Cancer Centre - Moorabin

In fase di reclutamento

East Melbourne, Victoria, 3002 AU

Icon Cancer Centre Richmond

In fase di reclutamento

Frankston, Victoria, 3199 AU

GenesisCare Radiation Oncology Centre Frankston

In fase di reclutamento

Geelong, Victoria, 3220 AU

University Hospital Geelong

In fase di reclutamento

Ringwood East, Victoria, 3135 AU

Ringwood Radiation Oncology Centre

In fase di reclutamento

Taipei, TW

Taipei Medical University Hospital

In fase di reclutamento

Zurich, Zurich, 8091 CH

Universitätsspital Zürich

In fase di reclutamento

Sevilla, Sevilla, 41013 ES

Hospital Universitario Virgen del Rocío

In fase di reclutamento

Traralgon, Victoria, 3844 AU

Latrobe Regional Hospital

In fase di reclutamento

Taichung, 407204 TW

Taichung Veterans General Hospital

In fase di reclutamento

Taoyuan, 10449 TW

Chang-Gung Memorial Hospital

In fase di reclutamento

Bundaberg, Queensland, 4670 AU

Cancer Care Service - Bundaberg

In fase di reclutamento

Bundaberg, Queensland, 4670 AU

Cancer Care Service - Hervey Bay

In fase di reclutamento

Winterthur, Zurich, 8401 CH

Kantonsspital Winterthur

In fase di reclutamento

Lleida, ES

Hospital Universitari Arnoa de Vilanova de Lleida

In fase di reclutamento

Sevilla, Sevilla, 41009 ES

Hospital Universitario Virgen Macarena

In fase di reclutamento

Antofagasta, CL

Centro Oncologico del Norte

In fase di reclutamento

Santiago, Region Metropolitana, CL

Hospital Luis Tisne Brousse

In fase di reclutamento

Chêne-Bougeries, Geneva, 1224 CH

Hirslanden Clinique Des Grangettes

In fase di reclutamento

Zurich, Zurich, 8008 CH

Brust-Zentrum Zürich

In fase di reclutamento

Puente Alto, CL

Hospital Sotero del Rio

In fase di reclutamento

San Miguel, CL

Hospital Barros Luco Trudeau

In fase di reclutamento

Santiago, 1010 CL

Instituto Nacional del Cancer

In fase di reclutamento

Rosario, Santa Fe, S2000 AR

Sanatorio Britanico Rosariio

In fase di reclutamento

Sarmiento, R8500ACE AR

Clinica Viedma

In fase di reclutamento

Dublin, IE

St Luke's Radiation Oncology Network

In fase di reclutamento

Lecco, IT

ASST Ospedale A. Manzoni UOS Oncologia

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