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Radiation before surgery: a new hope for breast cancer patients?

NCT ID NCT05464667

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests giving radiation therapy before surgery to women aged 50+ with early-stage, hormone-positive breast cancer. The goal is to find the safest radiation dose and see how the tumor responds. Only 15 participants are enrolled, making this a very early-stage trial.

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 lead to a new treatment option that allows doctors to see how the tumor responds to radiation before surgery, potentially improving outcomes.
What could go wrong
This is a very early, small trial (15 people) focused on finding the safest dose, not on curing cancer. It may not work for all patients, and side effects like skin irritation are possible.

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

15 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Jan 2030

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: 1. Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day "0" 2. Patient biologically of the female sex 3. Must meet ALL the following criteria: 3.1. Age ≥ 50 years 3.2. Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging. 3.3. All invasive subtypes and DCIS 3.4. ER positive, HER2/neu negative 3.5. No LVSI 3.6. Clinically negative lymph nodes based on results of dedicated breast imaging 4. The gross tumor should be \>1cm from the chest wall and the skin surface 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 within 90 days prior to registration 6. Patients of child-bearing age should have either a negative urine or serum pregnancy test within 14 days of study entry. 7. Patients of child-bearing age should be non-pregnant and non-lactating. They should use a medically acceptable form of contraception during RT. 8. Patients must have signed this study's informed consent prior to study entry. Exclusion Criteria: 1. Clinically staged breast cancer that does not meet all of the criteria delineated in Inclusion criteria 3. 2. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry 3. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix, melanoma in situ) unless disease free for a minimum of 5 years prior to study entry 4. Non-epithelial breast malignancies such as sarcoma or lymphoma. 5. Two or more documented breast cancers within the index breast or bilateral breast cancer. 6. Suspicious unresected microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. 7. Paget's disease of the nipple. 8. Male breast cancer. 9. Evidence of distant metastases. 10. Clinical regional lymph node involvement. 11. Prior RT to the region of the breast that would result in overlap of RT fields. 12. Intention to administer concurrent chemotherapy for current breast cancer. 13. Severe, active co-morbidity, defined as follows: 13.1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 13.2. Transmural myocardial infarction within the last 6 months 13.3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 13.4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration 13.5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol 13.6. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients. 14. Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 15. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent. 16. Unable to delineate tumor on pre-RT MRI and CT simulation scan.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • UPMC Magee Womens Hospital - Radiation Oncology

    Pittsburgh, Pennsylvania, 15213, United States

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