A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With … (NCT07386938) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
Russia246 participantsStarted 2024-08-09
Plain-language summary
The main purpose of this study is to prove non-inferiority, as well as to demonstrate the comparability of safety and immunogenicity of RPH-051 and Perjeta® in combination with trastuzumab and docetaxel as the 1st line therapy for patients with HER2-positive breast cancer (BC). Secondary Purposes are to evaluate the pharmacokinetics of RPH-051 in comparison with Perjeta® after a single-dose and repeated intravenous administration
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
. Histologically verified (documented results of respective examinations available) metastatic or locally recurrent unresectable breast adenocarcinoma (in case the results of previous examinations are not available, the diagnosis will be verified in the central laboratory during screening upon receipt and evaluation of the results before randomization)
. Patients with metastatic or locally recurrent unresectable breast cancer (BC) who have indications for the 1st line therapy
. HER2-positive tumor status, defined as 3+ points according to the results of immunohistochemical examination (IHC) and/or detected amplification of HER2 according to the results of fluorescence in situ hybridization (as defined by a ratio ≥ 2,0), evaluated using a validated test. The HER2 status analysis is carried out in the invasive component of a biopsy sample of tumor tissue during screening in the central laboratory. The results must be obtained before making a decision on randomization of the patient. For analysis, it is required to provide the blocks no more than 1 year old, obtained from the treatment-naive lesions, or a biopsy is performed as a part of screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Left ventricular ejection fraction (LVEF) ≥ 55 % during the screening.
. Presence of at least one measurable lesion in accordance with the RECIST 1.1 criteria (if the patient's only measurable lesion is a bone one, she cannot be enrolled in the study).
. Absence or resolution of the previous therapy toxic effects or negative consequences of surgeries of up to ≤ 1 gr. according to CTCAE 5.0, with the exception of chronic/irreversible adverse events that do not affect the safety parameters of the study therapy (for example, alopecia)
Exclusion criteria
. Previous antitumor therapy for metastatic or locally recurrent unresectable BC (neoadjuvant/adjuvant therapy with trastuzumab and one hormone therapy regimen for the metastatic process are allowed)
. Previous pertuzumab therapy
. The period without the signs of disease from the completion of the systemic neoadjuvant or adjuvant BC therapy (except hormonal therapy) to the established diagnosis of the metastatic process or recurrence in \< 12 months
. The period from completion of the systemic neoadjuvant or adjuvant BC therapy with trastuzumab and docetaxel to the start of the systemic therapy for metastatic or locally recurrent unresectable process with a combination of pertuzumab + trastuzumab + docetaxel is \< 12 months
. Sustained hematological toxicity (hemoglobin, leukocytes, neutrophils, platelets) ≥ grade 2, resulting from the previous adjuvant therapy
. Peripheral neuropathy ≥ grade 3 at the time the ICF is signed
. Other oncological pathology that is progressing or requires antitumor therapy (including hormonal therapy) within 5 years before signing the ICF, except radically removed cervical carcinoma in situ or radically removed basal cell/squamous cell skin carcinoma
. Central nervous system metastases that are progressive or accompanied by clinical symptoms (for example, cerebral edema, compression of the spinal cord), or require the application of glucocorticosteroids (GCS) at a dose equivalent to daily intake of prednisolone \> 10 mg (or dexamethasone \> 1.5 mg), and/or anticonvulsants. Patients with brain metastases can be included in the study if they receive adequate therapy (surgery or radiotherapy) and are stabilized according to the imaging studies data for at least 4 weeks before the expected date of randomization into the study. Patients with CNS metastases detected for the first time as a part of screening, which are not accompanied by neurological symptoms and do not require any therapy, can be included in the study