Skip to content
TrialMatch
Sign up
Recruiting

Safety and Efficacy of IMPT or IMRT for Breast Cancer

Create a profile to match View the full record on ClinicalTrials.gov

About this study

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Condition
Breast Cancer, Proton Therapy, Intensity Modulated Radiation Therapy, Efficacy and Safety, Radiotherapy, Adjuvant
Tested
Postoperative radiotherapy, Preoperative Radiotherapy, Definitive Radiotherapy
Sponsor
Ruijin Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Breast Cancer, Proton Therapy, Intensity Modulated Radiation Therapy, Efficacy and Safety, Radiotherapy, Adjuvant
  • Aged ≥18 years old
  • Karnofsky Performance Status (KPS) score ≥70
  • Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.
  • ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.
  • Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.
  • Ability to understand and willingness to participate in the research and sign the informed consent form.

Exclusion 4

  • Pregnant or lactating women.
  • Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.
  • Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.
  • Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.

Where

1 site, 1 recruiting

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.