Recurrent Breast CancerRENATANCT06329089
Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer
An observational study of Recurrent Breast Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Recurrent Breast Cancer
- What is being tested?
- Reoperative Sentinel Lymph Node Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises individuals who are over 18 years old and have been diagnosed with ipsilateral local recurrence of breast cancer, confirmed histologically with tumor sizes ranging from clinical stage cT1 to cT3. These patients must have a history of prior axillary surgery, including both sentinel lymph node biopsy and lymphadenectomy. Exclusion from the study includes patients with confirmed axillary metastasis, diagnosed inflammatory carcinoma, or suspected or confirmed distant metastasis based on staging studies. Additionally, individuals unable to undergo sentinel lymph node biopsy due to allergies to the radiotracer or mobility limitations are excluded from participation.
Who may be able to join
- Patients >18 years old with ipsilateral local recurrence of breast cancer with clinical stage cT1-3 cN0 confirmed by histology, with a history of previous axillary surgery (both sentinel lymph node biopsy and lymphadenectomy).
Who cannot join
- Patients with confirmed axillary metastasis (histology/immunohistochemistry)
- Inflammatory carcinoma
- Patients with suspected or confirmed distant metastasis on staging studies
- Inability to perform the sentinel lymph node biopsy technique: allergy to radiotracer, mobility limitation
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Ines Torras Caral, 93 227 54 00 ext. 2499, itorras@clinic.cat
About this study
Official title: RENATA Study: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches
The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:
- What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?
- How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?
Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team.
Read the detailed description
Prospective multicentric collection will be conducted for all patients diagnosed with ipsilateral recurrent breast cancer, who meet the criteria and are eligible for surgery, and who wish to participate in the study. Additional examinations and treatments will be performed according to standard clinical practice. Tests not included in routine practice will not be conducted.
Suspicion of axillary involvement will be ruled out using ultrasound or magnetic resonance imaging, as well as distant metastasis with standard staging studies (bone scintigraphy/computed tomography of the thorax, abdomen, and pelvis).
Lymphatic mapping will be performed according to each hospital's protocol, similar to lymphatic mapping in primary breast cancer. The radiotracer/dye will be injected according to each center's standard practice (peritumoral, intratumoral, intradermal, or periareolar in the quadrant of the tumor) the day before or on the day of surgery by Nuclear Medicine/Radiology. Lymphoscintigraphy will be performed, and the detected sentinel lymph nodes (SLNs) will be marked on the skin with ink/marker. In cases where the SLN is not visualized, a second dose of radiotracer may be administered.
If there is no drainage from the SLN and no prior lymphadenectomy (LA), additional axillary surgery will not be performed. If there is no drainage from the SLN and no prior LA, consideration will be given to performing lymphadenectomy according to each center's protocol.
During surgery, SLNs will be identified using a gamma probe and/or dye, with assistance from the nuclear medicine service. Between one and three SLNs will be removed (whether drainage is in the ipsilateral axilla, internal mammary, or contralateral axilla). They will be sent to Pathology for intraoperative or deferred examination (by One-Step Nucleic Acid Amplification (OSNA) or conventional technique).
If infiltration is found in any of the axillary SLNs (isolated tumor cells, micrometastasis, or macrometastasis), axillary surgery will be completed with a lymphadenectomy including levels I and II of Berg. If infiltration is found in internal mammary SLNs and not in axillary SLNs, irradiation of the internal mammary chain will be performed (recommended dose of 50 Gy), without completing the LA. If contralateral axillary SLNs are affected, further treatment will be decided by consensus in the subsequent treatment committee.
A wound care visit with a specialized breast unit nurse will be scheduled for the week after surgery to assess postoperative complications, and an outpatient consultation with Gynecology will be scheduled for 3 weeks after surgery for further evaluation.
Adjuvant treatment will be administered according to consensus in the hospital's multidisciplinary committee, following standard practice.
Follow-up will be conducted in outpatient consultations with Gynecology/Medical Oncology/Radiation Oncology, with physical examination every 4-6 months, and annual mammography and ultrasound, as per the consensus of the hospital's breast unit. A validated Spanish-language quality of life questionnaire following breast surgery (BREAST-Q) will be administered by Gynecology at 12 months post-surgery, along with evaluation of late postoperative complications.
- Conditions
- Recurrent Breast Cancer
- Being tested
- Reoperative Sentinel Lymph Node Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reoperative Sentinel Lymph Node BiopsyProcedure or surgery
Reoperative sentinel lymph node biopsy refers to a surgical procedure performed when there is a need to re-examine the sentinel lymph nodes (SLNs) in patients who have previously undergone breast cancer surgery. The sentinel lymph nodes are the first lymph nodes to which cancer cells are likely to spread from the primary tumor. During the procedure, the surgeon locates and removes the previously identified sentinel lymph nodes using techniques such as lymphatic mapping and injection of a radiotracer or dye. The removed lymph nodes are then examined by a pathologist to determine if there is any evidence of cancer spread.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent ipsilateral breast cancer | Recurrent ipsilateral breast cancer refers to the return of breast cancer in the same breast where it originally developed or was treated. Receives: Procedure: Reoperative Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-Sentinel Lymph node harvesting rate
Calculation of SLN identification rate and analysis of subgroups based on previous axillary surgery.
Measured: 12 months
Drainage pathways description
Describe and study the drainage pathways including the ipsilateral axilla, the internal mammary chain, and the contralateral axilla
Measured: 12 months
Secondary outcomes (4)
Complications rate
Analyze the surgical complications of the axillary, internal mammary, and contralateral axillary SLN technique in patients with previous axillary surgery.
Measured: 12 months
Axillary metastasis rate
Calculate the rate of axillary metastatic infiltration and lymphadenectomy in patients with ipsilateral recurrent breast cancer and axillary negative clinical stage (cN0)
Measured: 12 months
Correlation Between Axillary and Internal Mammary Chain Infiltration
Investigate the relationship between axillary and internal mammary chain infiltration
Measured: 12 months
Quality of life in recurrent breast cancer
Assess the quality of life in patients undergoing re-intervention for ipsilateral recurrent breast cancer using a validated questionnaire (Breast-Q).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329089
- Sponsor's protocol ID
- HCB/2023/0840
- Acronym
- RENATA
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENATA Study: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches
- ClinicalTrials.gov ID
- NCT06329089
- Acronym / sponsor ID
- RENATA / HCB/2023/0840
- Conditions
- Recurrent Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Mar 2024 (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.
The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:
- What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?
- How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?
Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team.
Detailed description
Prospective multicentric collection will be conducted for all patients diagnosed with ipsilateral recurrent breast cancer, who meet the criteria and are eligible for surgery, and who wish to participate in the study. Additional examinations and treatments will be performed according to standard clinical practice. Tests not included in routine practice will not be conducted.
Suspicion of axillary involvement will be ruled out using ultrasound or magnetic resonance imaging, as well as distant metastasis with standard staging studies (bone scintigraphy/computed tomography of the thorax, abdomen, and pelvis).
Lymphatic mapping will be performed according to each hospital's protocol, similar to lymphatic mapping in primary breast cancer. The radiotracer/dye will be injected according to each center's standard practice (peritumoral, intratumoral, intradermal, or periareolar in the quadrant of the tumor) the day before or on the day of surgery by Nuclear Medicine/Radiology. Lymphoscintigraphy will be performed, and the detected sentinel lymph nodes (SLNs) will be marked on the skin with ink/marker. In cases where the SLN is not visualized, a second dose of radiotracer may be administered.
If there is no drainage from the SLN and no prior lymphadenectomy (LA), additional axillary surgery will not be performed. If there is no drainage from the SLN and no prior LA, consideration will be given to performing lymphadenectomy according to each center's protocol.
During surgery, SLNs will be identified using a gamma probe and/or dye, with assistance from the nuclear medicine service. Between one and three SLNs will be removed (whether drainage is in the ipsilateral axilla, internal mammary, or contralateral axilla). They will be sent to Pathology for intraoperative or deferred examination (by One-Step Nucleic Acid Amplification (OSNA) or conventional technique).
If infiltration is found in any of the axillary SLNs (isolated tumor cells, micrometastasis, or macrometastasis), axillary surgery will be completed with a lymphadenectomy including levels I and II of Berg. If infiltration is found in internal mammary SLNs and not in axillary SLNs, irradiation of the internal mammary chain will be performed (recommended dose of 50 Gy), without completing the LA. If contralateral axillary SLNs are affected, further treatment will be decided by consensus in the subsequent treatment committee.
A wound care visit with a specialized breast unit nurse will be scheduled for the week after surgery to assess postoperative complications, and an outpatient consultation with Gynecology will be scheduled for 3 weeks after surgery for further evaluation.
Adjuvant treatment will be administered according to consensus in the hospital's multidisciplinary committee, following standard practice.
Follow-up will be conducted in outpatient consultations with Gynecology/Medical Oncology/Radiation Oncology, with physical examination every 4-6 months, and annual mammography and ultrasound, as per the consensus of the hospital's breast unit. A validated Spanish-language quality of life questionnaire following breast surgery (BREAST-Q) will be administered by Gynecology at 12 months post-surgery, along with evaluation of late postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent ipsilateral breast cancer | – | Procedure: Reoperative Sentinel Lymph Node BiopsyRecurrent ipsilateral breast cancer refers to the return of breast cancer in the same breast where it originally developed or was treated. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises individuals who are over 18 years old and have been diagnosed with ipsilateral local recurrence of breast cancer, confirmed histologically with tumor sizes ranging from clinical stage cT1 to cT3. These patients must have a history of prior axillary surgery, including both sentinel lymph node biopsy and lymphadenectomy. Exclusion from the study includes patients with confirmed axillary metastasis, diagnosed inflammatory carcinoma, or suspected or confirmed distant metastasis based on staging studies. Additionally, individuals unable to undergo sentinel lymph node biopsy due to allergies to the radiotracer or mobility limitations are excluded from participation.
Key inclusion criteria (1 listed)
- Patients >18 years old with ipsilateral local recurrence of breast cancer with clinical stage cT1-3 cN0 confirmed by histology, with a history of previous axillary surgery (both sentinel lymph node biopsy and lymphadenectomy).
Key exclusion criteria (4 listed)
- Patients with confirmed axillary metastasis (histology/immunohistochemistry)
- Inflammatory carcinoma
- Patients with suspected or confirmed distant metastasis on staging studies
- Inability to perform the sentinel lymph node biopsy technique: allergy to radiotracer, mobility limitation
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 |
|---|---|---|
| Reoperative Sentinel Lymph Node BiopsyReoperative sentinel lymph node biopsy refers to a surgical procedure performed when there is a need to re-examine the sentinel lymph nodes (SLNs) in patients who have previously undergone breast cancer surgery. The sentinel lymph nodes are the first lymph nodes to which cancer cells are likely to spread from the primary tumor. During the procedure, the surgeon locates and removes the previously identified sentinel lymph nodes using techniques such as lymphatic mapping and injection of a radiotracer or dye. The removed lymph nodes are then examined by a pathologist to determine if there is any evidence of cancer spread. | Procedure or surgery | Recurrent ipsilateral breast cancer |
Primary outcome
Re-Sentinel Lymph node harvesting rate
Time frame: 12 months
Calculation of SLN identification rate and analysis of subgroups based on previous axillary surgery.
Drainage pathways description
Time frame: 12 months
Describe and study the drainage pathways including the ipsilateral axilla, the internal mammary chain, and the contralateral axilla
4 secondary outcomes
Complications rate
Time frame: 12 months
Axillary metastasis rate
Time frame: 12 months
Correlation Between Axillary and Internal Mammary Chain Infiltration
Time frame: 12 months
Quality of life in recurrent breast cancer
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Recurrent Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 2
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
Triple-negative Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
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. This study is not recruiting at the moment.
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 Recurrent Breast Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines Torras, MD (93 227 54 00 ext. 2499, itorras@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Sentinel Lymph node harvesting rate (time frame: 12 months). The study lists 2 primary outcomes in all. 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 25 Mar 2024.