Single-cell RNAseq Breast Cancer

Breast Neoplasms Clinical Trial

— SCRBC  

Official title:

Study of the Impact of Neoadjuvant Therapy on the Heterogeneity of Triple Negative Breast Cancer Through Single-cell RNA Sequencing (scRNAseq) and Whole-exome Sequencing (WES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807516
• Other study ID #: RS1637/21
• Status: Recruiting
• Start date: December 14, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Regina Elena Cancer Institute
• Contact: Giovanni Blandino
• Phone: +39 06 52662911
• Email: giovanni.blandino[@]ifo.gov.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells, for example, M2 macrophages, could strongly contribute to identifying targeted therapeutic approaches for this disease.

Description:

Triple negative breast cancer (TNBC) represents approximately 15-20% of all breast cancers. Its features are lack of expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (Her2). TNBC exhibits a biologically aggressive behavior and a high inter- and intra-tumor molecular heterogeneity which has recently been highlighted also in single cell RNAseq (scRNAseq) studies. Patients with TNBC often have less positive outcomes then other breast cancer subtypes, due to the absence of specific therapeutic targets. Results of single cell RNA sequencing (scRNAseq) in TNBC before and after treatment with chemotherapy (NAC) were recently reported for a small group of patients. Genetic alterations are also investigated by Whole Exome Sequencing (WES). In addition scRNAseq analysis confirmed the presence of a high percentage of M2 macrophages in TNBC and tumor-adjacent tissue. These macrophages are clinically relevant and able to predict outcome in TNBC. Based on the above evidence, we hypothesize that molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells, for example, M2 macrophages, could strongly contribute to identifying targeted therapeutic approaches for this disease. We will conduct a pilot study with a combined retrospective and prospective observational design. Cancer patients diagnosed with histologically proven primary invasive breast cancer with a stage IIA to IIIB and assessed at the molecular level and defined as TNBC, will be eligible to participate to the study. Furthermore, only patients with a tumor >1.5cm in size will be considered, which is the selection criterion for the administration of neoadjuvant therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with histologically proven primary invasive breast cancer >1.5cm in size, with molecular assessed stage IIA to IIIB defined as TNBC, and who will undergo neoadjuvant chemotherapy and subsequent surgery (and/or have undergone - retrospective part).
• informed consent (prospective part)

Exclusion Criteria:

• pregnancy, metastatic breast cancer, previous chemotherapy, hormone therapy, radiation therapy, previous other cancers or contralateral breast cancer

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Single-cell RNA sequencing (scRNAseq), whole-exome sequencing (WES)
Combined both retrospective and prospective observational design

Locations

Country	Name	City	State
Italy	Policlinico Umberto I	Roma
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate chemoterapy effect	Decipher, through the execution of scRNAseq profiles, the transcriptional reprogramming that occurs during chemotherapy (NAC) in triple negative breast cancers (TNBC) and provide information of prognostic and/or predictive relevance of response to NAC	26 months