A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer
Launched by SHANGHAI PROTON AND HEAVY ION CENTER · Jan 11, 2023
Trial Information
Current as of August 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to treat certain types of early breast cancer, specifically HER2-positive and triple-negative breast cancer, after surgery. Standard treatment usually includes radiation therapy, but these types of cancer often do not respond as well to radiation. Researchers are exploring the use of a combination of proton and carbon ion radiation to see if it can reduce the chances of the cancer coming back. This study is currently recruiting women aged 18 to 80 who have had their tumors removed through breast-conserving surgery and have been diagnosed with either HER2-positive or triple-negative breast cancer.
If you join this trial, you will receive the new type of radiation therapy after your surgery. It’s important to know that you must meet certain criteria, like having a confirmed diagnosis of one of the eligible cancer types and not having any distant spread of the disease. The goal of this trial is to find out if this new treatment can help improve outcomes for patients with these specific types of breast cancer. If you’re interested or think you might qualify, it’s a good idea to talk to your doctor for more information.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry \[IHC\] 3+ and or fluorescence in situ hybridization \[FISH\] amplified; Triple Negative: estrogen receptor \[ER\] and progesterone receptor \[PR\] \< 1%, HER2 negative \[IHC 1+ or 2+ FISH non-amplified\])
- • Age ≥ 18 years and ≤ 80 years.
- • The primary tumor must be excised via breast conserving surgery.
- • Stage p T1-2 N0 M0
- • ECOG performance status ≤2.
- Exclusion Criteria:
- • Invasive breast cancer not confirmed by pathology.
- • Distant metastasis
- • Prior thoracic radiation.
- • Pregnancy or lactating.
About Shanghai Proton And Heavy Ion Center
The Shanghai Proton and Heavy Ion Center is a leading clinical trial sponsor dedicated to advancing cancer treatment through innovative radiation therapy techniques. With a focus on proton and heavy ion therapies, the center aims to enhance the precision and effectiveness of cancer care while minimizing side effects. Equipped with state-of-the-art technology and a multidisciplinary team of experts, the center conducts rigorous clinical research to evaluate the safety and efficacy of novel treatment modalities, ultimately striving to improve patient outcomes and contribute to the global body of oncology knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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