## Protocol Section
### Identification Module
**NCT ID:** NCT06361979

**Brief Title:** SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases

**Official Title:** A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases

#### Organization Study ID Info
**ID:** A1811
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-12
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-04-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Huihua Xiong

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Huihua Xiong

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases

### Conditions Module

**Conditions:**

- Breasr Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: SHR-A1811

- Drug: Bevacizumab

**Label:** ARM1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ARM1

**Description:** SHR-A1811: intravenous

**Name:** SHR-A1811

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ARM1

**Description:** Bevacizumab:intravenous

**Name:** Bevacizumab

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria

**Measure:** CNS-ORR

**Time Frame:** Up to 2 years

#### Secondary Outcomes

**Description:** PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first

**Measure:** PFS

**Time Frame:** up to 2 years

**Description:** ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1

**Measure:** ORR

**Time Frame:** Up to 2 years

**Description:** Proportion of participants experienced adverse events during the study period

**Measure:** AE

**Time Frame:** Up to 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. ≥18 years old;
2. Pathologically confirmed HER2-positive breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
5. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
6. Adequate function of major organs-

Exclusion Criteria:

1. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
2. Previous treatment with bevacizumab;
3. Participated in other drug clinical trials within 4 weeks before admission;
4. History of clinically significant lung disease；
5. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
6. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
7. Any other conditions that researchers believe that patients are unsuitable for this study.

   -

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xionghuihua@hotmail.com

**Name:** Xiong huihua

**Phone:** 13886073988

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology

**Name:** Xiong huihua

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M5209

- Name: Brain Neoplasms

- Relevance: HIGH

- As Found: Brain Metastases

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001932

- Term: Brain Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000006131

- Term: Growth Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M246

- Name: Bevacizumab

- Relevance: HIGH

- As Found: Non-

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068258

- Term: Bevacizumab

### Misc Info Module

- Version Holder: 2024-05-24
