Finding the best radiation dose for early-stage breast cancer before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine the most effective dose of stereotactic ablative breast radiotherapy for treating early-stage breast cancer prior to standard partial mastectomy or axillary surgery. It focuses on women aged 50 and older with specific cancer characteristics, including receptor status and clinical staging. Participants will receive radiation therapy in a shorter timeframe, potentially improving treatment efficiency and outcomes. The study will assess the safety and effectiveness of this approach compared to traditional methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female, ≥ 50 years of age.
2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment
3. Histologically confirmed invasive breast cancer.
4. Clinical stage T1N0M0.
5. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.
6. Unifocal breast cancer.
7. Eastern Cooperative Oncology Group (ECOG) 0, 1.
8. Ability to undergo MRI.
9. Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
10. Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).

Exclusion Criteria:

1. Patients without histologically confirmed invasive breast cancer.
2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.
3. Patients with metastatic disease.
4. ECOG 2, 3, 4.
5. Patients that are unable to undergo MRI.
6. Prior history of radiation to the chest.
7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
8. Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.
10. Patients unable to consent, who are pregnant or nursing, or are prisoners.

Where it's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Cristiane Takita, MD, MBA — University of Miami
• Study coordinator: Zuzel Rodriguez
• Email: z.rodriguez1@med.miami.edu
• Phone: 305-243-0124

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using blood-based tumor DNA (ctDNA) to find leftover breast cancer after treatment

  This research will test whether a simple blood test that looks for tiny bits of tumor DNA can tell if people treated for breast cancer (including HR+/HER2-, HER2+, and triple-negative) still have leftover cancer or are at risk of recurrence.

  Recruiting at 16 sites Tempus AI · Birmingham, Alabama and 15 other locations · NCT07211178

• Switching aromatase inhibitors versus guideline-based side-effect care to help with AI side effects

  This test tries switching one aromatase inhibitor to another versus using guideline-based side-effect care to see which helps postmenopausal women with early-stage ER-positive breast cancer stay on their hormone therapy.

  Recruiting Phase 2 Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT07071038

• Radiation therapy for early-stage breast cancer using a shorter treatment schedule

  This study is testing a shorter radiation treatment schedule for women 50 and older with early-stage breast cancer to see if it is safe and effective while reducing the number of visits needed.

  Recruiting Phase 2 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06902311

• Using Biolosion with standard therapy to treat triple-negative breast cancer

  This study is testing if adding a new oral probiotic called Biolosion to standard treatment can help women with locally advanced triple-negative breast cancer have better outcomes.

  Recruiting Phase 2 Sun Yat-sen University · Lanzhou, Gansu and 4 other locations · NCT06768931

• Water-only fasting to improve chemotherapy for early-stage breast cancer

  This study is testing if fasting for 24-48 hours can help make chemotherapy work better and be easier to tolerate for people with early-stage breast cancer.

  Recruiting Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Washington D.C., District of Columbia · NCT06536881

• Precision neoadjuvant therapy for operable breast cancer

  This study is testing if a personalized treatment approach using new drugs for operable breast cancer can work better than standard chemotherapy alone.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT05582499

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.