Breast CancerNCT05444647
Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study
An observational study of Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- stool and blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to Jun 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: early stage HER2-positive breast cancer patients
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Wei Li, Ph.D, 025-68307102, real.lw@163.com
About this study
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.
Read the 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
- Being tested
- stool and blood collection
- Keywords
- HER2-positive, neoadjuvant, microbiome
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool and blood collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HER2-positive | patients with newly diagnosed early stage HER2-positive breast cancer with an indication for standard trastuzumab-containing neoadjuvant treatment. Receives: Procedure: stool and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Correlations between Pathologic complete Response
Determine if specific microbiota correlated with the probability of pCR are associated with the anti-tumor innate and adaptive immune responses in the peripheral blood
Measured: 2 years
Side effects
Correlation of the microbiome to incidence of at least grade 3 toxicity using the CTCAE version 4.0 scoring
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444647
- Sponsor's protocol ID
- 20210601
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study
- ClinicalTrials.gov ID
- NCT05444647
- Acronym / sponsor ID
- 20210601
- Conditions
- Breast Cancer
- Keywords
- HER2-positive, neoadjuvant, microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-positive | – | Procedure: stool and blood collectionpatients with newly diagnosed early stage HER2-positive breast cancer with an indication for standard trastuzumab-containing neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- early stage HER2-positive breast cancer patients
Key inclusion criteria (11 listed)
- 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%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool and blood collectionPatients 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. | Procedure or surgery | HER2-positive |
Primary outcome
Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
Time frame: 2 years
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 secondary outcomes
Correlations between Pathologic complete Response
Time frame: 2 years
Side effects
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Li, Ph.D (025-68307102, real.lw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.