Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study

NCT ID: NCT05444647

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2025-06-30

Brief Summary

In this study the characteristics and alterations of the gut microbiome during neoadjuvant therapy for HER2-positive breast cancer patients are studied, as well as the relation between the gut microbiome and probability of pCR.

Detailed Description

Although systemic treatment for early stage HER2-positive breast cancer is becoming increasingly effective, resistance and side effects of current treatment modalities are substantial. There is an urgent need for novel therapies, and in addition, better predictive tools are needed to select the right drug to the right patient. New data suggest that modulation of the microbiome of the gut might provide opportunities to increase anti-tumor efficacy of cancer therapies.

A better understanding of the composition, function and dynamics of the gut microbiome before and during trastuzumab-containing neoadjuvant treatment might help to identify factors that can be influenced during the treatment of patients with primary HER2-positive BC .

This study will prospectively enroll 100 participants with newly diagnosed HER2-positive breast cancer patients undergoing standard of care trastuzumab-containing neoadjuvant treatment and correlate gut microbiome composition with pCR.

Patients will be treated with the standard of care neoadjuvant therapy. Stool and peripheral blood (PB) samples will be collected at time of consent for therapy, mid-treatment, after the completion of neoadjuvant treatment (at the discretion of the medical oncologist). Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible connection with pCR and side effects will be explored.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HER2-positive

patients with newly diagnosed early stage HER2-positive breast cancer with an indication for standard trastuzumab-containing neoadjuvant treatment.

stool and blood collection

Intervention Type: PROCEDURE

Patients will collect fecal and blood samples prior to treatment and at the time of response evaluation, and completion of therapy using a standard stool-collection-kit. At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.

Interventions

stool and blood collection

Patients will collect fecal and blood samples prior to treatment and at the time of response evaluation, and completion of therapy using a standard stool-collection-kit. At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Female, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.

2. Primary tumor greater than (>) 2 cm in diameter.

3. Age ≥ 18 years and < 70 years.

4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1.

5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55%

6. Availability of tumor tissue specimen after surgery.

7. Histologically proven diagnosis of breast cancer.

8. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).

9. Had hormonal receptors (ER and PgR) assessed.

10. Signed informed consent.

11. Able to comply with the protocol.

Exclusion Criteria

1. prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy

2. Prolonged antibiotic treatment > 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection

3. Uncontrolled inflammatory bowel disease

4. pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Li, Ph.D

Role: CONTACT

real.lw@163.com

025-68307102

Facility Contacts

Wei Li, Ph.D

Role: primary

real.lw@163.com

025-68307102

Other Identifiers

20210601

Identifier Type: -

Identifier Source: org_study_id