Effectiveness of Efavirenz along with chemotherapy in breast cancer patients

Effectiveness and safety of Efavirenz with neoadjuvant chemotherapy in the management of breast cancer: A Randomized, Placebo-controlled, Double-blind clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077808

Enrollment

100

Registered

2024-12-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: D059- Unspecified type of carcinoma in situ of breast

Interventions

Intervention1: Efavirenz along with chemotherapy: Dose: 600mg, Route Of Administration: Oral (Tablet), Frequency: Once daily, Total Duration: 3-6 months Control Intervention1: Placebo along with chem

Route of administration: Oral (Tablet), Frequency: Once daily, Total Duration: 3-6 months

Eligibility

Inclusion criteria

Inclusion criteria: Breast cancer patients of any stage planned for neo-adjuvant chemotherapy, Patients must be able to take oral medications, Patients willing to give informed consent

Exclusion criteria

Exclusion criteria: Pregnant and breast-feeding women Patients receiving hormonal therapy or radiotherapy Patients who have dementia, any psychiatric condition or mental retardation that would prohibit the understanding or signing of informed consent. Patients on Antiretroviral therapy

Design outcomes

Primary

Measure	Time frame
Clinical response and pathological complete responseTimepoint: Baseline, 3rd month, 4th month	—

Secondary

Measure	Time frame
1. To evaluate the safety and tolerability of efavirenz when added to neoadjuvant chemotherapy through Adverse event assessment with laboratory parameters 2. To assess Medication adherence 3. To assess the Quality of LifeTimepoint: 3-6 months	—

Countries

India

Contacts

Public ContactDR MG Rajanandh

SRM Institute of Science and Technology

karthiks18@srmist.edu.in9964839602

Outcome results

None listed

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