Clinical trial NCT03856372: Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer
Official title: Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Postmastectomy Hypofractionated Adjuvant Radiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 1494
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly.

Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.

The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.

It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.

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
* 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

Primary outcomes:
measure: Loco-regional recurrence (LRR)
timeFrame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Secondary outcomes:
measure: Distant metastasis free survival (DMFS)
timeFrame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
measure: Disease free survival (DFS)
timeFrame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
measure: Overall survival (OS)
timeFrame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
measure: CTCAE Toxicity Assessment-Acute toxicity
timeFrame: before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received, every year through 10 years
measure: CTCAE Toxicity Assessment-Late toxicity
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: LENT-SOMA Toxicity Assessment
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Number of patients with Arm Lymphedema
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Number of patients with impaired shoulder movement (Range of motion of the shoulders)
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Number of patients with symptomatic rib fracture
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Number of patients with brachial plexopathy
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Number of patients with reconstruction complications
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Cosmetic outcomes for patients received mastectomy with reconstruction
timeFrame: before treatment, every year after the last fraction received through 10 years
measure: Quality of Life Life-EORTC QLQ-C30 (version 3)
timeFrame: before treatment, the end of treatment, every year after the last fraction received through 10 years
measure: Quality of Life-EORTC breast-cancer module (BR23)
timeFrame: before treatment, the end of treatment, every year after the last fraction received through 10 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal hospital
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Huangpu Branch, Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jinli Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: