Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
1,494 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for women aged 18 to 75 who have been treated for high risk breast cancer with surgery. Participants will compare two types of radiation therapy to see how effective they are and what side effects they may have.
Are You a Good Fit for This Trial?
You may be able to join if
I am a female
I am between 18 and 75 years old
I have been diagnosed with invasive breast cancer
I have had a mastectomy and lymph node removal
I have negative surgical margins
I have certain risk factors related to my cancer
I have no distant cancer spread
I am fit for radiation therapy
You may not be able to join if
I have had another cancer besides certain skin cancers
I have had previous radiation therapy to my chest
I have serious health issues with my heart or breathing
I have conditions that prevent me from having radiation therapy
I do not have the necessary risk factors for my cancer stage
I have known spread of cancer to other areas
I have bilateral breast cancer or past invasive cancer on the other side
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Female
* Age18-75 years
* Pathologically confirmed invasive breast cancer
* Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
* Negative surgical margins
…
Inclusion Criteria:
* Female
* Age18-75 years
* Pathologically confirmed invasive breast cancer
* Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
* Negative surgical margins
* Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
* No distant metastases
* No supraclavicular or internal mammary nodes metastases
* ECOG:0-1
* Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
* No neoadjuvant chemotherapy
* Fit for postoperative radiotherapy. No contraindications to radiotherapy
* Signed informed consent
Exclusion Criteria:
* Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
* Previous radiotherapy to the chest wall or regional lymph node areas
* Patients with severe non-malignant comorbidity in cardiovascular or respiration system
* Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
* pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
* Patients with supraclavicular or internal mammary nodes metastases
* Known definitive clinical or radiologic evidence of metastatic disease
* Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
* Treated with neoadjuvant chemotherapy
* ECOG: 3-4
* Pregnant or lactating
* Conditions indicating that the patient cannot go through the radiation therapy or follow up
* Unable or unwilling to sign informed consent
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