NCT05444647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

June 23, 2022

Last Update Submit

July 5, 2022

Conditions

Breast Cancer

Keywords

HER2-positiveneoadjuvantmicrobiome

Outcome Measures

Primary Outcomes (1)

  • Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)

    The primary objective of this study is to determine if the probability of pCR (pathologic complete response) in HER2-positive breast cancer patients treated with standard of care neoadjuvant therapy is correlated with variability in the composition of intestinal microbiota and subsequent short-term alterations in that composition.

    2 years

Secondary Outcomes (2)

  • Correlations between Pathologic complete Response

    2 years

  • Side effects

    2 years

Study Arms (1)

HER2-positive

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

Procedure: stool and blood collection

Interventions

stool and blood collectionPROCEDURE

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.

HER2-positive

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

early stage HER2-positive breast cancer patients

You may qualify if:

  • Female, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
  • Primary tumor greater than (\>) 2 cm in diameter.
  • Age ≥ 18 years and \< 70 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
  • Availability of tumor tissue specimen after surgery.
  • Histologically proven diagnosis of breast cancer.
  • 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).
  • Had hormonal receptors (ER and PgR) assessed.
  • Signed informed consent.
  • Able to comply with the protocol.

You may not qualify if:

  • prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy
  • Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection
  • Uncontrolled inflammatory bowel disease
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool and blood sample

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Defecation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Wei Li, Ph.D

CONTACT

025-68307102real.lw@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 6, 2022

Study Start

July 1, 2022

Primary Completion

May 1, 2024

Study Completion

June 1, 2025

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations

CN(1)