Phase III Randomized Study of Trastuzumab, Pertuzumab, and Docetaxel in HER2-Positive Early Breast Cancer

The primary objective of this randomized phase III study is to evaluate whether the addition of **pertuzumab** to an adjuvant regimen containing trastuzumab and chemotherapy enhances invasive disease-free survival in patients with HER2-positive early **breast cancer**. This is clinically significant as improving invasive disease-free survival can potentially lead to better long-term outcomes and reduce the risk of cancer recurrence in this patient population.

Secondary objectives include investigating whether adding pertuzumab to the adjuvant treatment regimen improves overall survival. This aspect is crucial for understanding the broader impact of pertuzumab on patient longevity and quality of life.

The clinical trial focuses on evaluating the efficacy of adding pertuzumab to an adjuvant regimen containing trastuzumab and chemotherapy in improving invasive disease-free survival among patients with **HER2-positive early breast cancer**. The study population comprises women over the age of 18, with confirmed invasive HER2-positive breast cancer. The trial exclusively includes female participants, with no male subjects involved, and does not target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on specific inclusion criteria, including age and confirmed diagnosis. No additional lifestyle considerations such as diet or physical activity are specified in the available data.

The clinical trial is designed as a **randomized**, **double-blind**, and controlled study to evaluate the efficacy of adding **pertuzumab** to an adjuvant regimen containing trastuzumab and chemotherapy in patients with HER2-positive early **breast cancer**. The primary objective is to assess whether this combination improves invasive disease-free survival. Secondary endpoints include overall survival, distant disease-free survival, left ventricle ejection fractions, adverse event rate, and quality of life. The trial is expected to run from December 2015 to June 2025, with a maximum treatment period of 9 months for each participant.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility, which requires women over 18 years of age with confirmed invasive HER2-positive breast cancer. Following randomization, participants will receive the study medication intravenously, with the dosing regimen including a maximum daily dose of 840 mg and a total dose of 1680 mg. Follow-up visits will be scheduled to monitor the participants' health status, treatment efficacy, and any adverse events. The end-of-study visit will conclude the trial for each participant, assessing the final outcomes and collecting data for analysis.

The expected length of participant involvement is up to 9 months, with conditions for early termination including significant adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial is conducted under strict regulatory guidelines to ensure the safety and well-being of all participants, with data collected contributing to the understanding of treatment efficacy in HER2-positive early breast cancer.

The clinical trial involves the administration of **Perjeta** (pertuzumab), a **concentrate for solution for infusion**. This experimental medication is provided in a pharmaceutical form suitable for intravenous administration. The dosage regimen includes an initial loading dose of 840 mg, followed by a maintenance dose of 420 mg every three weeks. The maximum treatment period is nine cycles. Pertuzumab is a monoclonal antibody targeting the HER2 receptor, classified under the ATC code L01XC13. The active substance, pertuzumab, is derived from a protein of non-human origin. Compliance with the dosing schedule is monitored through regular assessments to ensure adherence to the treatment protocol.

In addition to the experimental treatment, the study includes a comparator arm where participants receive the current standard regimen for early HER2-positive breast cancer. This regimen typically involves trastuzumab and chemotherapy, including docetaxel. The trial aims to evaluate the efficacy of adding pertuzumab to this standard regimen in improving invasive disease-free survival. The administration of the comparator treatment follows established guidelines for dosage and frequency, ensuring consistency across study sites. Participant compliance with the comparator treatment is similarly monitored to maintain the integrity of the trial data.

Efficacy in this clinical trial will be assessed primarily through the measurement of **invasive disease-free survival** in patients with HER2-positive early breast cancer. This primary endpoint will evaluate the effectiveness of adding pertuzumab to an adjuvant regimen containing trastuzumab and chemotherapy. Secondary endpoints include overall survival, distant disease-free survival, left ventricle ejection fractions, adverse event rate, and quality of life. These parameters will provide a comprehensive assessment of the treatment's impact on patient health and disease progression.

The trial will employ a randomized phase III design, comparing the combination of trastuzumab, pertuzumab, and docetaxel (TPD) followed by three cycles of chemotherapy to the current standard regimen. The efficacy parameters will be collected and analyzed at various timepoints throughout the study, although specific timepoints are not detailed in the provided data. The study aims to determine whether the addition of pertuzumab improves outcomes in the specified patient population.