Phase 3 Breast Cancer Trial, Recruiting NCT03671044 Sponsor: Jina Pharmaceuticals Inc. Condition: Breast Cancer
Back to Breast Cancer

Phase 3 Breast Cancer Trial, Recruiting

NCT03671044
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing to give written, signed, and dated consent to take part in the study.
  • People who have been confirmed through laboratory testing to have triple negative breast cancer.
  • People who have received no more than one chemotherapy treatment after surgery and/or one chemotherapy treatment for cancer that has spread.
  • People whose breast cancer has spread locally or to other parts of the body and has stopped responding to prior chemotherapy.
  • People who have at least one tumour that can be measured using standard imaging criteria (confirm with trial site).
  • People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scoring system (confirm with trial site).
  • People whose heart pumping function, measured by an ultrasound of the heart, is at or above 50%.
  • People who have recovered from any side effects of previous chemotherapy or radiation, as assessed by the study doctor.
  • People who completed their last chemotherapy or radiation treatment at least 4 weeks before the start of the trial treatment.
  • People who are expected to live for at least 6 months.
  • People whose pregnancy tests (blood test at screening and urine test on Day 1) are negative.
  • Women who are sexually active and able to become pregnant must be using an effective form of contraception for at least 4 weeks before starting the trial, throughout the trial, and for 30 days after the last dose (confirm with trial site for accepted contraception methods).
  • People with adequate bone marrow, kidney, and liver function as determined by blood tests.

Who may not be able to join:

  • People who have had an allergic reaction to Docetaxel, any of its ingredients, or any medicine containing polysorbate 80.
  • People who have a history of a breast cancer type that is HER2 positive or hormone receptor positive (ER or PR positive).
  • People who have already received Docetaxel treatment for cancer that has spread to other parts of the body.
  • People with certain heart conditions, including unstable chest pain, a heart attack in the past 6 months, severe uncontrolled irregular heartbeat, significant disease around the heart, signs of reduced blood supply to the heart on an ECG, or a history of heart disease rated at a moderate-to-severe level by a standard medical classification (confirm with trial site).
  • People with uncontrolled diabetes or an active uncontrolled infection.
  • People with a known history of drug addiction within the past year.
  • People with known cancer spread to the brain or the lining of the brain, unless those brain lesions are not causing any symptoms.
  • People who have taken part in another clinical trial or received an experimental medicine within 30 days before starting this trial.
  • People who already have nerve damage (affecting movement or sensation) at or above a certain level of severity before the trial begins (confirm with trial site).
  • People with a known HIV infection.
  • People with any other condition that the study doctor believes could increase risk or affect the quality of the study results.
  • People who are unwilling or unable to follow the requirements of the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dr. Ravi Alamchandani, Lambda Therapeutic Research Ltd.

Phone: +917940202375

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Jina Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
10 July 2018
Est. completion
31 May 2025

Where this trial is recruiting

🇮🇳 India 🇺🇸 United States

Primary endpoints

Proportion of the patients with Objective Response Rate (i.e., CR + PR) as the Best Overall Response Rate (i.e., CR + PR) in the test arm (NDLS) compared to reference arm (Taxotere)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov