Recruiting PHASE2, PHASE3 Breast Cancer

New treatment option for Breast Cancer

Official title Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer

ClinicalTrials.gov ID: NCT05804916

What this study is testing

What it's testing
This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment.
  • Phase 3: a large, late-stage study
  • 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 to 70, women only

You may be able to join if

  • Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
  • Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
  • Able to perform deep inspiration breath-hold technique with breath-holding time \>35s and can repeat it continuously for more than 6 times;
  • Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
  • No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;

You likely can't join if

  • Bilateral breast cancer;
  • No pathological diagnosis;
  • Remote metastasis;
  • Receiving neoadjuvant chemotherapy or breast reconstruction;
  • Have received mediastinal radiotherapy in the past;
  • Previous history of abdominal or pelvic radiotherapy;
See the full eligibility criteria
Who can join
  • Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
  • Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
  • Able to perform deep inspiration breath-hold technique with breath-holding time \>35s and can repeat it continuously for more than 6 times;
  • Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
  • No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
  • Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.
What rules you out
  • Bilateral breast cancer;
  • No pathological diagnosis;
  • Remote metastasis;
  • Receiving neoadjuvant chemotherapy or breast reconstruction;
  • Have received mediastinal radiotherapy in the past;
  • Previous history of abdominal or pelvic radiotherapy;
  • Previous or secondary primary malignant tumor;
  • Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, Beijing Municipality, China

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 to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, Beijing Municipality, China. 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.