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Triple Negative Breast CancerPhase 3BCTOP-T-M03NCT05954442

Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype

A Phase 3 study testing Everolimus and Investigator's Choice of Chemotherapy in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM)… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Everolimus and Investigator's Choice of Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteChina
Study dates
13 Sep 2023to Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients need to meet all of the following conditions
  • Patients must be ≥18 and ≤ 70 years of age;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
  • The expected survival is more than 3 months;
  • Pathologically confirmed breast cancer is triple negative breast cancer (IHC ER < 1%, PR<1%, HER2 0 OR +, if HER2++, FISH negative), and LAR subtype with mutation in PAM pathway;
  • Recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible;.
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  • No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
  • Patients with at least one lesion (measurable and/or unmeasurable) that has not previously received radiation therapy can be accurately evaluated by CT/MRI at baseline and can be evaluated repeatedly according to RECIST 1.1;
  • The functions of the main organs are basically normal, and the following conditions are met:
  • Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
  • Biochemical examination shall meet the following standards: TBIL≤1.5× upper limit of normal value(ULN); alanine aminotransferase (ALT) and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula);
  • Patients have not received radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks prior to study initiation, and have recovered from acute toxic effects of prior treatment (if surgery is present, the wound has fully healed); No peripheral neuropathy or grade I peripheral neurotoxicity;
  • Fertile female are required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
  • Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.

Who cannot join

  • Patients with any of the following conditions were excluded from the study:
  • Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, enhanced CT or enhanced MRI must be performed within 28 days before the first dose to rule out central nervous system metastasis.
  • A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
  • Persistent grade ≥1 adverse events due to previous treatment. The exception to this is hair loss or something the researchers believe should not be ruled out. Such cases should be clearly documented in the investigator's notes;
  • Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access);
  • Pregnant or lactating patients;
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  • Other malignancies within the previous 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma;
  • Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
  • There is a third space effusion that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites);
  • Participated in other anti-tumor drug clinical trials within 4 weeks before taking the study drug for the first time;
  • Long-term unhealed wounds or incomplete healing fractures;
  • Patients with known Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection active phase or hepatitis B DNA≥500, or chronic phase with abnormal liver function;
  • Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
  • The investigator does not consider the patient suitable for participation in any other circumstances of the study.

Trial locations and contacts

1 site in 1 country.

Zhimin Shao, MD, PhD contact

+86-021-64175590 ext. 88807

zhimingshao@yahoo.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Zhimin Shao, M.D., Ph.D., 86-021-64175590, zhimingshao@yahoo.com

    Recruiting

Other trials in China

About this study

Official title: An Open, Randomized Phase III Study of Everolimus With Investigator's Choice of Chemotherapy Versus Chemotherapy in The First-Line Treatment of Luminal Androgen Receptor (LAR) Subtype With PI3K/AKT/mTOR Pathway Mutation of Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer (BCTOP-T-M03)

The goal of this clinical trial is to evaluate the efficacy of investigator's choice of chemotherapy, either alone or in combination with everolimus, in treating patients with locally recurrent inoperable or metastatic triple-negative breast cancer, luminal androgen receptor (LAR) subtype with PI3K/AKT/mTOR (PAM) pathway mutation, as the first-line treatment.

Read the detailed description

Eligible participants will be those diagnosed with estrogen receptor (ER)-negative [Immunohistochemistry (IHC) ER positive <1% ) , progesterone receptor (PR) negative(IHC PR positive <1% ) , and human epidermal growth factor receptor 2 (HER2)-negative [IHC 0 or +; or IHC ++, Fluorescence in situ hybridization (FISH) -], LAR subtype with PAM pathway mutation locally recurrent inoperable or metastatic breast cancer, who have received no prior chemotherapy, targeted therapy or other treatments.

The study is aimed to evaluate the efficacy of investigator's choice (ICC) of chemotherapy (nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone) either alone or in combination with everolimus. This study aims to see if everolimus plus chemotherapy allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving investigator's choice of chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Being tested
Everolimus, Investigator's Choice of Chemotherapy
Keywords
triple negative breast cancer, metastatic breast cancer, PI3K/AKT/mTOR mutation
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Afinitor

    Everolimus is a kind of mTOR inhibitors which has been approved to use in several kinds of cancers, especially in metastatic breast cancer .

  • Investigator's Choice of ChemotherapyDrug

    Also called ICC

    Investigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat metastatic triple negative breast cancer, including nab-paclitaxel, capecitabine, eribulin, carboplatin, vinorelbine, or utidelone.

Study groups in NCT05954442
Study groupRoleWhat they receive
Arm AExperimentalEverolimus plus Investigator's Choice of Chemotherapy
Receives: Drug: Everolimus; Drug: Investigator's Choice of Chemotherapy
Arm BActive comparatorInvestigator's Choice of Chemotherapy
Receives: Drug: Investigator's Choice of Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.

    Measured: Approximately 3 years

Secondary outcomes (6)

  1. Objective response rate (ORR)

    The proportion of participants who have a complete response (CR) or partial response (PR) according to RECIST 1.1.

    Measured: Approximately 3 years

  2. Duration of response (DoR)

    The interval from date of first detection of objective response until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.

    Measured: Approximately 3 years

  3. Disease control rate (DCR)

    The proportion of participants with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated.

    Measured: Approximately 3 years

  4. Overall survival (OS)

    The interval from randomization until the date of death due to any cause.

    Measured: Approximately 3 years

  5. Safety and tolerability

    Number of adverse events according to NCI-CTCAE Version 5.0 per each treatment arm

    Measured: Approximately 3 years

  6. Number of participants with patient reported outcome (PRO)

    A report directly from a patient about his or her health or life quality by EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire and 28 out of 30 items are scored on a 4-point Likert response scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. The EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptomatology.

    Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start13 Sep 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05954442
Sponsor's protocol ID
SCHBCC-N058
Acronym
BCTOP-T-M03
Status last verified
Jan 2024
First submitted
13 Jul 2023
Last updated
16 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus and Investigator's Choice of Chemotherapy in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhimin Shao, MD, PhD (+86-021-64175590 ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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