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NCT Number: NCT03177902

Evaluation of Thyroid Abnormity Incidence and Thyroid Toxicity During Chemotherapy Among Newly Diagnosed Breast Cancer

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.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location status: Recruiting

Location contact

Qiong Wu, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Yan Yang, M.D., Ph.D.

CONTACT

[email protected]

+86-552-3086178

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Chemotherapy

Drug

Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Yang, M.D.,Ph.D.

CONTACT

[email protected]

+86-552-3086178

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Bengbu Medical University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2017
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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