OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer

Description

Background Triple negative breast cancer (TNBC) is a subtype of breast cancer characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) expression. TNBC is associated with a higher risk of recurrence and poorer prognosis compared to other breast cancer subtypes. Currently, the standard of care for early stage TNBC includes adjuvant chemotherapy, typically consisting of anthracyclines and taxanes. However, this regimen is associated with significant toxicities and adverse effects.

This clinical trial aims to evaluate the combination of liposomal doxorubicin and carboplatin as an adjuvant therapy for patients with early stage TNBC. Previous studies conducted in the neoadjuvant setting have shown promising results with this combination, indicating a reduction in the risk of recurrence. Additionally, the combination has demonstrated a more favorable tolerability profile compared to the current standard of care. Therefore, this trial seeks to assess the efficacy and safety of liposomal doxorubicin and carboplatin in the adjuvant setting for TNBC.

The primary objective of this clinical trial is to determine the efficacy of liposomal doxorubicin and carboplatin as adjuvant therapy for early stage TNBC. The efficacy will be measured by evaluating the recurrence-free survival (RFS) rate at a specified time point.

The secondary objectives of this study include: Characterizing the safety and toxicity profile of the combination therapy, as measured by the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Assessing the overall survival (OS) rate in patients receiving liposomal doxorubicin and carboplatin. Evaluating the pathological complete response (pCR) rate following the treatment regimen. Analyzing the disease-free survival (DFS) rate in patients treated with the combination therapy. In addition to the primary and secondary objectives, this study also aims to explore the following: Investigating changes in circulating tumor DNA (ctDNA) levels as a potential biomarker for treatment response and disease progression. Exploring correlations between specific genetic markers and treatment outcomes.

This study is a multicenter, open-label, phase II clinical trial. The study will enroll patients with early stage TNBC who have undergone surgical resection of the primary tumor. Patients in the study will receive adjuvant therapy consisting of liposomal doxorubicin and carboplatin. The dosing and administration schedule will be determined based on established guidelines and previous studies.

The sample size calculation will be based on statistical considerations, taking into account the primary endpoint of recurrence-free survival. A predetermined number of patients will be required to achieve adequate statistical power.

Eligible patients will be enrolled and undergo baseline assessments, including medical history, physical examination, laboratory tests, and imaging studies. Treatment will be initiated according to the predetermined dosing and administration schedule. Patients will be closely monitored throughout the study for treatment response, adverse events, and disease recurrence.

Follow-up visits will be scheduled at specified time intervals to assess long-term outcomes and collect additional data.