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NEODOXy: Doxycycline in Early ER+/HER2- Breast Cancer

NCT06452394Phase 2

Key facts

Status: Recruiting
Start: Jul 2025
Primary completion: Jun 2028
Countries: 1
Sponsor: Swiss Group for Clinical Cancer Research
Modality: Small Molecules

Drugs: doxycycline
Conditions: breast cancer

Overview

Phase 2, open-label, single-arm trial of doxycycline in breast cancer, sponsored by Swiss Group for Clinical Cancer Research. Primary endpoints: Difference in the proportion of patients with ALDH1 positive tumors and Pathologic complete response rate. Started Jul 2025; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

NEOadjuvant DOXYcycline
Neoadjuvant chemotherapy (epirubicin + cyclophosphamide followed by paclitaxel) + doxycycline.

Who it enrols

Adult patients with early-stage ER+/HER2- primary invasive breast cancer (tumor size >= 2 cm, cN0-3) planned for neoadjuvant chemotherapy, with adequate organ function and ECOG PS 0-1.

Endpoints

Primary

Difference in the proportion of patients with ALDH1 positive tumorsFrom registration to 30 days after last trial treatment
Pathologic complete response rateFrom registration to 30 days after last trial treatment

Secondary

Percentage of ALDH1 positive tumor cellsFrom registration to 30 days after last trial treatment
Difference in the percentage of ALDH1 positive tumor cellsFrom registration to 30 days after last trial treatment
Pathological residual diseaseFrom registration to 30 days after last trial treatment
Radiological tumor shrinkageFrom registration to 30 days after last trial treatment
Breast conservation rateFrom registration to 30 days after last trial treatment
Doxycycline adherence rateFrom registration to 30 days after last trial treatment
Patient-reported treatment burdenFrom registration to 30 days after last trial treatment

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