A study to understand the differences in the cell cycle phase distribution and establish dormancy signature in patients on sequential vs concurrent chemo-endocrine therapy in hormone receptor positive and HER2 negative non-metastatic breast cancer

Experimental pilot study to evaluate differences in cell cycle phase distribution and establish dormancy signature in patients on sequential vs concurrent chemo-endocrine therapy in the neoadjuvant setting in hormone receptor positive and HER2 negative non-metastatic breast cancer - Trans-Consequence

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044399

Enrollment

Registered

2022-07-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: True cut biopsy in patients undergoing neo-adjuvant chemotherapy/ neo-adjuvant endocrine chemotherapy: Patients in the study would be undergoing a true cut biopsy before undergoing neo-

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing treatment in Consequence study CTRI/2018/09/015643 2. Non-metastatic, biopsy proven breast cancer ER and/or PR positive HER2 negative. 3. Age > 18 yrs 4. Fit to receive chemotherapy 5. Written, informed consent 6. Planned to receive both chemo and endocrine therapy in the adjuvant or neo-adjuvant setting

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women 2.Patients who are candidates to receive only 3.endocrine treatment (low risk of recurrence) 4.Inflammatory breast carcinoma 5.Women who have received prior chemo/hormonal therapy for breast cancer 6.Co-existing non-breast malignancy (such as hematolymphoid/ovarian cancer)

Design outcomes

Primary

Measure	Time frame
Flow cytometry analysis of cell cycle phase distribution in 2 arms NACT and NACT-HTTimepoint: 1.Baseline tumour tissue trucut biopsy before starting neoadjuvant chemotherapy and 3-5 ml blood. 2.Tumour tissue biopsy at the time of surgery and 3-5ml blood.	—

Secondary

Measure	Time frame
1) To extract RNA from live sorted G0 cells for analysis of tumour dormancy signature 2) CTC isolation and analysisTimepoint: 1.Baseline tumour tissue trucut biopsy before starting neoadjuvant chemotherapy and 3-5 ml blood. 2.Tumour tissue biopsy at the time of surgery and 3-5ml blood.	—

Countries

India

Contacts

Public ContactDr Shalaka Joshi

Tata Memorial Hospital

drjoshishalaka@gmail.com02224177198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026