Breast Cancer FemaleNCT03177902
Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer
An observational study of Breast Cancer Female and Thyroid Gland, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
Breast cancer is one of the most common cancers in China. Even though advances in the field of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer Female, Thyroid Gland
- What is being tested?
- Chemotherapy
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2017to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- Women only
- Adult, Older adult
Study population: Newly diagnosed female breast cancer
Who may be able to join
- Female patients with histologically or cytologically proven primary breast cancer;
- Age >18 years;
- ECOG Performance Status: 0-2;
- Life Expectancy: 3 months or more;
- No previous anti-cancer therapy;
- Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy;
- Adequate hematological, liver, and kidney functions.
Who cannot join
- Pregnancy or lactation;
- History of other malignancy or secondary breast cancer;
- History of thyroid disease;
- History of drug addiction or abuse;
- History of immunodeficiency disease;
- Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry;
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- Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
- Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
- Inability to understand and agree to informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Yan Yang, M.D., Ph.D., +86-552-3086178, qiannianhupo@163.com
Qiong Wu, M.D., Ph.D.
About this study
Official title: A Prospective Study to Assess Both Thyroid Abnormity Incidence In Chinese Women With Newly Diagnosed Breast Cancer and Thyroid Toxicity of Breast Cancer Patients Undergoing Chemotherapy
Breast cancer is one of the most common cancers in China. Even though advances in the field of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality. The cytotoxic therapies are generally associated with some immediate or otherwise delayed side effects, such as adverse effects on gastrointestinal, hepatic, renal and hematological systems. The effect of chemotherapy on endocrine system, however, is comparatively less envisaged. Several epidemiological studies show a positive association between plasma thyroid hormones levels and breast cancer risk. Thyroid dysfunction is emerging as a variably common endocrine toxicity of several anticancer drugs. Due to the scarcity of data on the functioning of thyroid gland during chemotherapy in a large scale group, the present study was aimed to investigate the incidence of thyroid abnormity in Chinese women with newly diagnosed breast cancer, and also the effects of chemotherapy on thyroid gland functions or structure in these breast cancer patients undergoing at least four cycles of chemotherapy.
- Conditions
- Breast Cancer Female, Thyroid Gland
- Being tested
- Chemotherapy
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy Receives: Drug: Chemotherapy | |
| Control group | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants newly diagnosed with breast cancer
Rate of thyroid function (measured by chemiluminescence methods) or structure (measured by ultrasonic imaging) abnormity at the time of diagnosis and during chemotherapeutic period will be reported.
Measured: 1 week around the indicated detection point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start4 Jun 2017
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Yang, MD, Ph.D, The First Affiliated Hospital of Bengbu Medical University
- Investigators
- Qiong Wu, M.D.,Ph.D., Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177902
- Sponsor's protocol ID
- BYEC20170502
- Status last verified
- Sep 2026
- First submitted
- 28 May 2017
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess Both Thyroid Abnormity Incidence In Chinese Women With Newly Diagnosed Breast Cancer and Thyroid Toxicity of Breast Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT03177902
- Acronym / sponsor ID
- BYEC20170502
- Conditions
- Breast Cancer Female, Thyroid Gland
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 4 Jun 2017 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jun 2017 (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.
Breast cancer is one of the most common cancers in China. Even though advances in the field of breast cancer therapeutics, chemotherapy remains the mainstay therapeutic modality. The cytotoxic therapies are generally associated with some immediate or otherwise delayed side effects, such as adverse effects on gastrointestinal, hepatic, renal and hematological systems. The effect of chemotherapy on endocrine system, however, is comparatively less envisaged. Several epidemiological studies show a positive association between plasma thyroid hormones levels and breast cancer risk. Thyroid dysfunction is emerging as a variably common endocrine toxicity of several anticancer drugs. Due to the scarcity of data on the functioning of thyroid gland during chemotherapy in a large scale group, the present study was aimed to investigate the incidence of thyroid abnormity in Chinese women with newly diagnosed breast cancer, and also the effects of chemotherapy on thyroid gland functions or structure in these breast cancer patients undergoing at least four cycles of chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Drug: ChemotherapyNewly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy |
| Control group | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed female breast cancer
Key inclusion criteria (7 listed)
- Female patients with histologically or cytologically proven primary breast cancer;
- Age >18 years;
- ECOG Performance Status: 0-2;
- Life Expectancy: 3 months or more;
- No previous anti-cancer therapy;
Key exclusion criteria (9 listed)
- Pregnancy or lactation;
- History of other malignancy or secondary breast cancer;
- History of thyroid disease;
- History of drug addiction or abuse;
- History of immunodeficiency disease;
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 |
|---|---|---|
| ChemotherapyNewly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy. | Drug | Observational group |
Primary outcome
Number of participants newly diagnosed with breast cancer
Time frame: 1 week around the indicated detection point
Rate of thyroid function (measured by chemiluminescence methods) or structure (measured by ultrasonic imaging) abnormity at the time of diagnosis and during chemotherapeutic period will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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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.
Qiong Wu, M.D.,Ph.D. principal investigator
The First Affiliated Hospital of Bengbu Medical University
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 Female and Thyroid Gland, run by The First Affiliated Hospital of Bengbu 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Yang, M.D.,Ph.D. (+86-552-3086178, qiannianhupo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants newly diagnosed with breast cancer (time frame: 1 week around the indicated detection point). 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 4 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.