## Protocol Section
### Identification Module
**NCT ID:** NCT04809779

**Acronym:** NeoPD1TNBC

**Brief Title:** PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC

**Official Title:** PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer

#### Organization Study ID Info
**ID:** 2020466
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital, Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2024-03

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-03-22

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-19

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-03

**Type:** ESTIMATED

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2021-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-19
**Study First Submit QC Date:** 2021-03-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** First Affiliated Hospital, Sun Yat-Sen University

#### Responsible Party

**Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University

**Investigator Full Name:** Ying Lin

**Investigator Title:** Vice Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.

### Conditions Module

**Conditions:**

- Triple Negative Breast Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 49

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Sintilimab

**Label:** Sintilimab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sintilimab

**Description:** The PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments.

**Name:** Sintilimab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).

**Measure:** Pathologic Complete Response (pCR)

**Time Frame:** 21 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines.

Exclusion Criteria:

* Patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shaon@mail.sysu.edu.cn

**Name:** Nan Shao

**Phone:** 02087755766

**Phone Ext:** 8198

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** The First Affiliated Hospital of Sun Yat-sen University

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M30373

- Name: Triple Negative Breast Neoplasms

- Relevance: HIGH

- As Found: Triple Negative Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000064726

- Term: Triple Negative Breast Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M6727

- Name: Cyclophosphamide

- Relevance: LOW

- As Found: Unknown

- ID: M17954

- Name: Epirubicin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
