Concurrent chemo-endocrine treatment in hormone receptor positive breast cancer compared to sequential administration of the same

CONcurrent versus SEQuential Chemo-Endocrine therapy in ER positive and HER2 negative non-metastatic breast cancer (CONSEQuenCE) - CONSEQuenCE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015643

Enrollment

2432

Registered

2018-09-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Arm 1 Experimental Concurrent endocrine therapy with adjuvant or neoadjuvant chemotherapy: 1. Hormonal therapy in premenopausal women will be injection leuprolide depot 11.25 mg IM once

Eligibility

Inclusion criteria

Inclusion criteria: 1.Non-metastatic, biopsy proven breast cancer 2.ER and/or PR positive 3.HER2 negative 4.Age > 18 yrs 5.Fit to receive chemotherapy 6.Written, informed consent 7.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 endocrine treatment (low risk of recurrence) 3.Inflammatory breast carcinoma 4.Women who have received prior chemo/hormonal therapy for breast cancer 5.Co-existing non-breast malignancy (such as hematolymphoid/ovarian cancer)

Design outcomes

Primary

Measure	Time frame
To assess the improvement in disease free survival by administering concurrent versus sequential, (neo) adjuvant chemo-endocrine therapy in hormone receptor positive, HER2 negative, non-metastatic breast cancerTimepoint: 5 years	—

Secondary

Measure	Time frame
To assess improvement in overall survival, toxicity profile between the 2 treatment arms, pathological complete response rates in the neo-adjuvant setting ,Surgical resectability rate post neoadjuvant therapy in LABC, For any difference in the breast conservation rate in the neo-adjuvant setting, The efficacy of ovarian suppression with the 3 monthly ovarian suppression/ LHRHa by doing analysis of E2/FSH in premenopausal women. This will be done in at least the first 100 patients in each arm.Timepoint: 5 years	—

Measure

Time frame

To assess improvement in overall survival, toxicity profile between the 2 treatment arms, pathological complete response rates in the neo-adjuvant setting ,Surgical resectability rate post neoadjuvant therapy in LABC, For any difference in the breast conservation rate in the neo-adjuvant setting, The efficacy of ovarian suppression with the 3 monthly ovarian suppression/ LHRHa by doing analysis of E2/FSH in premenopausal women. This will be done in at least the first 100 patients in each arm.Timepoint: 5 years

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Countries

India

Contacts

Public ContactDr Shalaka P Joshi

Tata Memorial Hospital

drshalakajoshi@gmail.com02224177198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 13, 2026