BridgeMD
New treatment option for Acute Lung Injury
Official title PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
ClinicalTrials.gov ID: NCT05704166
What this study is testing
- What it's testing
- The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 75, women only
You may be able to join if
- To be enrolled in this study, patients must meet all of the following
- Breast invasive carcinoma or ductal carcinoma in situ or lobular carcinoma in situ confirmed by histology;
- Age 18-75, female;
- The physical state score of the Eastern Tumor Cooperative Group (ECOG) was 0-2;
- Patients meeting the indications of postoperative radiotherapy and neoadjuvant chemotherapy: clinical stage 3 or above or postoperative ypT3-T4 or...
You likely can't join if
- Patients with any of the following criteria were not enrolled in this study
- History and complications A. male breast cancer patients; B. Did not meet the conditions of large segmentation radiotherapy (upper and lower...
- Physical examination and laboratory examination A. A known history of testing positive for human immunodeficiency virus (HIV) or a known history of...
- As determined by the investigator, the patient may have other factors that may lead to the termination of the study, such as other serious diseases...
See the full eligibility criteria
- To be enrolled in this study, patients must meet all of the following
- Breast invasive carcinoma or ductal carcinoma in situ or lobular carcinoma in situ confirmed by histology;
- Age 18-75, female;
- The physical state score of the Eastern Tumor Cooperative Group (ECOG) was 0-2;
- Patients meeting the indications of postoperative radiotherapy and neoadjuvant chemotherapy: clinical stage 3 or above or postoperative ypT3-T4 or N+; Non-neoadjuvant chemotherapy patients: postoperative pathological...
- Radiotherapy regimen was chest wall + supraclavicular 40Gy/15f after root modification, or whole milk ± upper and lower clavicular 40Gy/15f after breast preservation, tumor bed simultaneous supplement 50Gy/15f;
- All screening period laboratory tests should be performed in accordance with protocol requirements and within 28 days prior to enrollment. The values of laboratory tests performed by screening must meet the following...
- Women who are at risk of becoming pregnant must undergo a negative serum pregnancy test within 7 days before the first dose and be willing to use a highly effective method of contraception during the trial period and...
- The people voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
- Patients with any of the following criteria were not enrolled in this study
- History and complications A. male breast cancer patients; B. Did not meet the conditions of large segmentation radiotherapy (upper and lower clavicular lymph node metastasis, internal milk lymph node metastasis, the...
- Physical examination and laboratory examination A. A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); B. untreated active...
- As determined by the investigator, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or serious abnormalities in laboratory tests or other factors that may...
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, 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.