Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could some breast cancer patients skip radiation? major trial seeks answers

NCT ID NCT02889874

Disease control Sponsor: Breast Cancer Trials, Australia and New Zealand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at whether women aged 50 and older with a specific low-risk type of early breast cancer (luminal A) can safely skip radiation therapy after surgery. About 1,167 participants are randomly assigned to receive either standard radiation plus hormone therapy or just hormone therapy alone. The goal is to see if the cancer comes back in the same breast at similar rates in both groups, which could spare many women from unnecessary radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy
What this could lead to
If successful, this could show that some women with low-risk breast cancer can safely skip radiation after surgery, reducing side effects and treatment burden.
What could go wrong
This is a non-inferiority trial, so it aims to prove that omitting radiation is not worse than having it. If it fails, women may face a higher risk of cancer returning in the same breast.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,167 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2017

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: for registration in the study: 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 Exclusion Criteria: 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Early-stage breast carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early-stage breast carcinoma

Contacts and locations

Locations

  • ASST Ospedale A. Manzoni UOS Oncologia

    Lecco, Italy

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Ballarat Austin Radiation Oncology Centre

    Ballarat, Victoria, 3353, Australia

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Brust-Zentrum AG Zurich

    Zurich, 8008, Switzerland

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298, Australia

  • Cancer Care Service - Bundaberg

    Bundaberg, Queensland, 4670, Australia

  • Cancer Care Service - Hervey Bay

    Bundaberg, Queensland, 4670, Australia

  • Centro Oncologico del Norte

    Antofagasta, Chile

  • Chang-Gung Memorial Hospital

    Taoyuan, 10449, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Clinica Viedma

    Sarmiento, R8500ACE, Argentina

  • Fondazione Oncologia Lago Maggiore

    Locarno, 6600, Switzerland

  • Genesis Cancer Care Newcastle

    Gateshead, New South Wales, 2290, Australia

  • Genesis Cancer Care Wesley

    Auchenflower, Queensland, 4066, Australia

  • GenesisCare Radiation Oncology Centre Frankston

    Frankston, Victoria, 3199, Australia

  • GenesisCare Tennyson

    Kurralta Park, South Australia, 5037, Australia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Hirslanden Clinique des Grangettes

    Chêne-Bougeries, 1224, Switzerland

  • Hospital Barros Luco Trudeau

    San Miguel, Chile

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Luis Tisne Brousse

    Santiago, Santiago Metropolitan, Chile

  • Hospital Sotero del Rio

    Puente Alto, Chile

  • Hospital Universitari Arnoa de Vilanova de Lleida

    Lleida, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Macarena

    Seville, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Icon Cancer Centre Richmond

    East Melbourne, Victoria, 3002, Australia

  • Instituto Nacional del Cancer

    Santiago, 1010, Chile

  • Instituto de Oncologia de Rosario

    Santa Fe, Argentina

  • Istituto Europeo di Oncologia

    Milan, Italy

  • Kantonsspital Winterthur

    Winterthur, 8400, Switzerland

  • Kaohsiung Medical University Hospital

    Kaohsiung City, Taiwan

  • Latrobe Regional Hospital

    Traralgon, Victoria, 3844, Australia

  • Liverpool Hospital

    Liverpool, New South Wales, 1871, Australia

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560, Australia

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Mater Hospital Sydney

    North Sydney, New South Wales, 2060, Australia

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Palmerston North Hospital

    Palmerston North, 4414, New Zealand

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 8006, Australia

  • Peter MacCallum Cancer Centre - Bendigo

    Bendigo, Victoria, 3550, Australia

  • Peter MacCallum Cancer Centre - Moorabin

    Bentleigh East, Victoria, 3165, Australia

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444, Australia

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Ringwood Radiation Oncology Centre

    Ringwood East, Victoria, 3135, Australia

  • Sanatorio Britanico Rosariio

    Rosario, Santa Fe Province, S2000, Argentina

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St Luke's Radiation Oncology Network

    Dublin, Ireland

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • St Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Taichung Veterans General Hospital

    Taichung, 407204, Taiwan

  • Taipei Medical University Hospital

    Taipei, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tamworth Rural Referral Hospital

    Tamworth, New South Wales, 2340, Australia

  • The Canberra Hospital

    Canberra, Australian Capital Territory, 2605, Australia

  • The Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Tri-Service General Hospital

    Taipei, 114, Taiwan

  • Universitatsspital Zurich

    Zurich, 8091, Switzerland

  • University Hospital Galway

    Galway, Ireland

  • University Hospital Geelong

    Geelong, Victoria, 3220, Australia

  • Waikato Hospital

    Hamilton, 3240, New Zealand

  • Wellington Hospital

    Wellington, 6021, New Zealand

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.