The BCD-178-2/PREFER clinical study will evaluate the efficacy and safety of BCD-178 (INN pertuzumab) and Perjeta® (INN pertuzumab) as neoadjuvant therapy1 in female patients who:
Are older than 18 years and younger than 75 years.
Have a documented diagnosis of invasive breast cancer with a primary tumor of more than 2 cm in diameter.
Have a HER2-positive tumor.
Have a tumor that does not express estrogen and progesterone receptors.
Are fully physically active and mobile.
The clinical study protocol requires a mastectomy or organ-preserving surgery.
This clinical study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, exclusion criteria include:
Metastatic form of the disease.
A history of invasive breast cancer.
Previous systemic therapy for breast cancer.
Bilateral breast cancer.
Previous biopsy with removal of the primary lesion and/or axillary lymph nodes.
Removal of axillary lymph nodes.
A history of other malignancy.
Other diseases, such as serious cardiovascular diseases, severe asthma, acute infectious diseases, etc.
A diagnosis of HIV infection, hepatitis B or C.
Current or previous alcohol or drug addiction.
Pregnancy, breastfeeding, or planned pregnancy at any time during the participation in the study and 6 months after the last dose of the drug.
Allergies to study drugs (pertuzumab, trastuzumab, docetaxel, paclitaxel, carboplatin).
The BCD-178-2/PREFER study takes place in study centers of different cities in the Russian Federation and the Republic of Belarus: Moscow, Saint Petersburg, Nizhny Novgorod, Novosibirsk, Omsk, Ufa, Kostroma, Sochi, Yaroslavl, Volgograd, Samara, Chelyabinsk, Arkhangelsk, Tomsk, Voronezh, Kazan, Minsk, Brest, Vitebsk, Gomel, Grodno, and Mogilev.
You can ask questions about participation in the clinical study and request contact information about study centers using a special form «Do you have any questions?».
The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.
Authorization of the Ministry of Health of the Russian Federation for this clinical study, No. 703 dated December 15, 2022, and the list of approved study centers have been published in the State Register of Medicines.
Authorization of the Ministry of Health of the Republic of Belarus for this clinical study, No. 11-14/876 dated January 25, 2023, and the list of approved study centers in the RB have been published in the State Register of Clinical Studies of the Republic of Belarus.
Neoadjuvant therapy is chemotherapy administered before the main treatment, usually surgery.