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NCT03630653: FIGARO
Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse
NA trial testing Sentinel LN in breast cancer recurrence in Invasive Breast Cancer in 50 participants. Terminated before completion.
3 December 2020
Quick facts
| Lead sponsor | Institut Cancerologie de l'Ouest |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 29 May 2018 |
| Primary completion | 3 December 2020 |
| Estimated completion | 3 December 2020 |
| Sites | 9 locations across France |
Drugs / interventions tested
- Sentinel LN in breast cancer recurrence
Conditions studied
- Invasive Breast Cancer — all drugs for Invasive Breast Cancer →
- Ipsilateral Recurrence — all drugs for Ipsilateral Recurrence →
- Sentinel Lymph Node Biopsy — all drugs for Sentinel Lymph Node Biopsy →
Sponsor
Institut Cancerologie de l'Ouest — full company profile →
Who can join
18 and older, any sex, with Invasive Breast Cancer or Ipsilateral Recurrence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer. Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed. There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored. Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer. In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging. Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted. In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery. The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03630653
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03630653 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Cancerologie de l'Ouest
- Last refreshed: 25 April 2022
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