An Open-label Phase II Trial Evaluating the Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer（NeoSACT）

Plain English Summary

The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC is a Phase 2 clinical trial sponsored by Guangdong Provincial People's Hospital studying Triple Negative Breast Cancer. This trial tests a combination of Sintilimab, Anlotinib, and chemotherapy as a treatment before surgery for early-stage triple-negative breast cancer. It is for patients newly diagnosed with early-stage triple-negative breast cancer that has not spread. Participants will receive the study treatment for about 6 months, followed by surgery, and then further monitoring. Standard treatment options for this condition typically involve chemotherapy, surgery, and sometimes radiation or targeted therapies. The trial aims to enroll 29 participants.

Official Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab plus anlotinib combined with chemotherapy as neoadjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Sintilimab + anlotinib + chemotherapy) based on schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 4-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary outcome measure is pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have newly diagnosed, locally advanced triple-negative breast cancer that has not spread to distant parts of the body. You cannot join if you have had cancer in the last 5 years (except for certain skin or cervical cancers), or if you have received certain cancer treatments in the past year. Participants must have a good general health status (ECOG 0 or 1) and adequate organ function. Women who can become pregnant must agree to use effective birth control during and after the study. This trial is studying Triple Negative Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see how many patients have no detectable cancer in their breast or lymph nodes after the treatment, meaning the therapy was highly effective in eliminating the cancer before surger The specific primary outcome measures are: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (Up to approximately 30-32 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to improve treatment outcomes for triple-negative breast cancer, a challenging form of breast cancer with limited targeted therapy options, by evaluating a novel combination therapy be Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Triple Negative Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial explores a combination therapy for a specific breast cancer subtype, indicating potential for new treatment strategies in a significant market segment. Success could lead to new drug approv Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific chemotherapy drugs used, the duration of treatment, and potential side effects. Participation involves regular clinic visits for treatment infusions, blood tests, scans, and check-ups over several months. You will undergo surgery after the pre-surgery treatment, and then be monitored for several years. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 29 participants

Interventions

• DRUG: Sintilimab — 200mg on days 1 (Q3W) of the neoadjuvant and adjuvant phase of the study; IV injection.
• DRUG: Anlotinib — 12mg on d1-14 of Cycles 1-8 (Q3W) of the neoadjuvant phase of the study; po. Arotinib is a small molecule multi-target TKI, which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.
• DRUG: Nab paclitaxel — 100 mg/m² on day 1, 8 and 15 of Cycles 1-4 (Q3W) of the neoadjuvant phase of the study; IV injection.
• DRUG: Carboplatin — AUC 5 on days 1 of Cycles 1-4 (Q3W) of the neoadjuvant phase of the study; IV injection.
• DRUG: Epirubicin — 90 mg/m² on day of Cycles 5-8 (Q3W) of the neoadjuvant phase of the study; IV injection.

Primary Outcomes

• Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (Up to approximately 30-32 weeks)

Secondary Outcomes

• Residual cancer burden (RCB) (Up to approximately 30-32 weeks)
• Event-free Survival (EFS) as assessed by Investigator (Up to approximately 3 years)
• Overall survival (OS) (Up to approximately 5 years)
• Immune response biomarkers (Up to approximately 60 weeks)
• Percentage of participants who experience an adverse event (AE) (Up to approximately 60 weeks)

Full Eligibility Criteria

Inclusion Criteria:

* Has newly diagnosed, locally advanced TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:

T1c, N1-N2 T2, N0-N2 T3, N0-N2 T4a-d, N0-N2

* Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
* Demonstrates adequate organ function.
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.

Exclusion Criteria:

* Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or antiangiogenic drug therapy.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
* Has received a live vaccine within 30 days of the first dose of study treatment.
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or Hepatitis C.
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
* Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
* Has a known hypersensitivity to the components of the study treatment or its analogs.
* Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).

Trial Locations

• NeoSACT, Guangzhou, Guangdong, China

Frequently Asked Questions

Related Conditions

• Triple Negative Breast Cancer
• Breast Cancer
• Oncology
• Neoadjuvant Therapy
• Immunotherapy
• Targeted Therapy
• Chemotherapy
• Angiogenesis Inhibitors
• Hormone Receptor Negative Breast Cancer
• HER2 Negative Breast Cancer

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