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NCT Number: NCT05838001

Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy

The standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Chang Gong, doctor

CONTACT

[email protected]

02034070499

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female patients, age≥18 year
  • A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
  • Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment.
  • Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery

Exclusion criteria

  • Inflammatory breast cancer or Paget's disease
  • Breast deformities and other conditions that impact breast conservation success rate
  • Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded.
  • Pregnancy or lactation
  • Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
  • Patients with stage IV diseases or unresectable lesions in either breast
  • Patients combined with other diseases that may affect survival
  • Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations
  • Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
  • Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy

Treatment and study plan

Wire-guided localization and marker clip localization

Procedure

Positioning guide wire and marker clip in the center of the breast lesion

marker clip localization

Procedure

Positioning marker clip in the center of the breast lesion

Primary outcomes

  1. Marginal positive rate

    Time frame: up to 3 months

    Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)

Secondary outcomes

  1. Re-operation rate.

    Time frame: up to 3 months

    the proportion of patients which have a positive margin and requires a re-operation

  2. The proportion of breast-conserving surgery.

    Time frame: up to 3 months

    It refers to the proportion of patients who have successfully undergone breast-conserving surgery.

  3. IDFS

    Time frame: 2 years, 3 years, and 5 years

    Time from surgery to the first occurrence of local, distant disease recurrence, or death.

Study contacts

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

Chang Gong, doctor

CONTACT

[email protected]

02034070499

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neo-adjuvant Therapy : a Prospective Randomized Control Trial.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Jul 3, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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