Preoperative radiation therapy for early-stage breast cancer

Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study

This study is testing if giving radiation therapy before surgery can help people with early-stage breast cancer do better and live longer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 50 Years and up
• Sex: Female
• Sponsor: University of Pittsburgh (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05464667 on ClinicalTrials.gov

What this trial studies

This trial evaluates the use of preoperative radiation therapy (RT) in patients with early-stage, biologically favorable breast cancer. It consists of two parts: a dose escalation phase to determine the maximum tolerated dose (MTD) of RT and a dose expansion phase for additional safety and efficacy assessment. Patients will receive varying doses of RT to assess tumor response and outcomes, aiming to improve access to RT and reduce mortality associated with underutilization. The study focuses on patients with specific eligibility criteria, including age and tumor characteristics.

Who should consider this trial

Good fit: Ideal candidates are women aged 50 and older with early-stage breast cancer that is ER positive and HER2/neu negative.

Not a fit: Patients with advanced breast cancer or those who do not meet the specific eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for early-stage breast cancer patients by improving tumor response assessment and reducing reliance on chemotherapy.

How similar studies have performed: Other studies have shown promise in using preoperative radiation therapy for breast cancer, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC Magee Womens Hospital - Radiation Oncology — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Parul Barry, MD — UPMC Hillman Cancer Center
• Study coordinator: Samantha Demko, RN, BSN

Conditions: Breast Cancer, Radiation Therapy