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New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Hypofractionated Radiotherapy Before or After Breast Surgery for Treatment of Patients With Non-Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06635980
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anatomic stage i breast cancer ajcc v8.
Also referred to as Chemo, Chemotherapy (NOS).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well hypofractionated radiotherapy before (preoperative) or after (postoperative) breast surgery works in treating patients with different types of non-metastatic (has not spread from original tumor site) breast cancer and to determine the outcomes and side effects of this treatment. Radiation therapy is considered an integral part of breast conserving therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age \>= 18 years
- Histological confirmation of breast cancer
- Clinical stage T1-T4 N0-3 M0
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
- Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent
You likely can't join if
- Medical contraindication to receipt of radiotherapy
- Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Active systemic lupus or scleroderma
- Pregnancy
- Women of childbearing potential who are unwilling to employ adequate contraception
See the full eligibility criteria
- Age \>= 18 years
- Histological confirmation of breast cancer
- Clinical stage T1-T4 N0-3 M0
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
- Able to and provides Institutional Review Board (IRB)-approved study specific written informed consent
- Able to complete all mandatory tests listed in the trial
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Indications for radiotherapy for breast cancer
- Medical contraindication to receipt of radiotherapy
- Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Active systemic lupus or scleroderma
- Pregnancy
- Women of childbearing potential who are unwilling to employ adequate contraception
- Prior receipt of ipsilateral breast or chest wall radiation
- Recurrent breast cancer
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.