Recruiting PHASE4 Breast Cancer

Compares treatment options for Breast Cancer

Official title Albumin-bound Paclitaxel and Carboplatin Versus Epirubicin and Docetaxel for Triple-negative Breast Cancer

ClinicalTrials.gov ID: NCT04136782

What this study is testing

What is Albumin-bound paclitaxel combined with carboplatin?

Albumin-bound paclitaxel combined with carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.

Also referred to as Albumin-bound paclitaxel+carboplatin group.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
To investigate the efficacy of albumin-bound paclitaxel combined with carboplatin versus epirubicin combined with docetaxel as neoadjuvant therapy for triple-negative breast cancer.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70, women only

You may be able to join if

  • patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2...
  • estimated survival \> 3 months;
  • presence of clinically measurable lesions;
  • Karnofsky functional status score ≥ 70;
  • normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations;

You likely can't join if

  • stage IV breast cancer patients with bone metastasis or other distant metastasis;
  • severe renal insufficiency;
  • older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy;
  • those who have received antineoplastic therapy;
  • those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate...
  • those with history of other malignant tumors;
See the full eligibility criteria
Who can join
  • patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III;
  • estimated survival \> 3 months;
  • presence of clinically measurable lesions;
  • Karnofsky functional status score ≥ 70;
  • normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations;
  • age at 18-70 years.
What rules you out
  • stage IV breast cancer patients with bone metastasis or other distant metastasis;
  • severe renal insufficiency;
  • older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy;
  • those who have received antineoplastic therapy;
  • those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy;
  • those with history of other malignant tumors;
  • those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens;
  • those with mental and nervous system diseases who cannot comply with treatment;
  • those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy;
  • pregnant or lactating women;
  • those who are participating in other trials.

The study team makes the final eligibility decision.

Where it's taking place

  • Harbin, Heilongjiang, China
  • Changchun, Jilin, China
  • Dalian, Liaoning, China
  • Panjin, Liaoning, China
  • Shenyang, Liaoning, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Harbin, Heilongjiang, China; Changchun, Jilin, China; Dalian, Liaoning, China; Panjin, Liaoning, China; Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.