Thyroid changes during chemotherapy in women with newly diagnosed breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll women with newly diagnosed breast cancer who plan to receive four cycles of anthracycline- or taxane-based chemotherapy. Researchers will monitor thyroid function and structure to identify the incidence of thyroid abnormalities and assess any association with chemotherapy. The work aims to provide population-level data on thyroid toxicity related to standard chemotherapy in this patient group. No experimental interventions beyond routine chemotherapy are involved. The lead site is The First Affiliated Hospital of Bengbu Medical University in Bengbu, Anhui, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients with histologically or cytologically proven primary breast cancer;
2. Age \>18 years;
3. ECOG Performance Status: 0-2;
4. Life Expectancy: 3 months or more;
5. No previous anti-cancer therapy;
6. Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy;
7. Adequate hematological, liver, and kidney functions.

Exclusion Criteria:

1. Pregnancy or lactation;
2. History of other malignancy or secondary breast cancer;
3. History of thyroid disease;
4. History of drug addiction or abuse;
5. History of immunodeficiency disease;
6. Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry;
7. Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
8. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
9. Inability to understand and agree to informed consent.

Where it's running

• Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Recruiting

Study contacts

• Principal investigator: Qiong Wu, M.D.,Ph.D. — The First Affiliated Hospital of Bengbu Medical University
• Study coordinator: Yan Yang, M.D.,Ph.D.
• Email: qiannianhupo@163.com
• Phone: +86-552-3086178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.