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Breast CancerPhase 2NCT02742051

A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer

A Phase 2 study testing Everolimus, Letrozole and Fluorouracil in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Everolimus, Letrozole and Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Jun 2016to 14 Mar 2020
Phase
Phase 2
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

  • The patients signed the written informed consent
  • The patients present with non-metastatic unilateral invasive ER-positive, HER2-negative breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging.
  • Postmenopausal women with age less than 70 years old.
  • The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy.
  • The patients have normal cardiac functions by echocardiography.
  • The patients' ECOG scores are ≤2.
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  • The patients can swallow pills.
  • The results of patients' blood tests are as follows:
  • Hb≥90g/L;
  • WBC≥4E+9/L;
  • Plt≥100E+9/L;
  • Neutrophils≥1.5E+9/L;
  • ALT and AST ≤ triple of normal upper limit;
  • TBIL ≤ 1.5 times of normal upper limit;
  • Creatinine ≤ 1.5 times of normal upper limit.

Who cannot join

  • The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
  • The patients have active infections that were not suitable for chemotherapy;
  • The patients have severe non-cancerous diseases.
  • The patients have bilateral breast cancers or multifocal breast cancers or inflammatory breast cancers.
  • The patients have a history of previous treatment with mTOR inhibitors.
  • The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
  • The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
  • The patients have allergic history or contraindication of any of the interventional drugs.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: A Randomised Pilot Study of Neoadjuvant Everolimus Plus Letrozole Compared With FEC in Postmenopausal Patients With ER-positive, HER2-negative Breast Cancer

This open, randomized pilot feasibility trial is to evaluate the feasibility and effect of neoadjuvant everolimus plus letrozole versus neoadjuvant fluorouracil, epirubicin plus cyclophosphamide (FEC) in treating postmenopausal women with ER-positive, HER2-negative breast cancer. Forty postmenopausal stage M0, ER-positive, HER2-negative invasive breast cancer women who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging were randomly (1:1) enrolled to receive neoadjuvant everolimus plus letrozole for 18 weeks or neoadjuvant FEC for 6 cycles before surgery. The primary objective is to determine the feasibility of neoadjuvant everolimus plus letrozole in postmenopausal patients with ER-positive, HER2-negative breast cancer. Secondary aims are to compare the ultrasound response rate, pathological complete response (pCR) rate, breast-conserving surgery rate, toxicities, and changes in the percentages or counts of peripheral blood CD4+ T cells, CD8+ T cells, tumor-specific CTLs, T helper cells (Th), regulatory T cells (Treg), and NK cells and changes in tumor Ki67 index (pre- versus post- neoadjuvant therapy).

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • EverolimusDrug

    Also called RAD001

    Neoadjuvant endocrine therapy

  • LetrozoleDrug

    Also called Femara

    Neoadjuvant endocrine therapy

  • FluorouracilDrug

    Also called 5-Fu

    Neoadjuvant chemotherapy

  • EpirubicinDrug

    Also called EPB

    Neoadjuvant chemotherapy

  • CyclophosphamideDrug

    Also called CTX

    Neoadjuvant chemotherapy

Study groups in NCT02742051
Study groupRoleWhat they receive
Everolimus+LetrozoleExperimentaleverolimus 10mg/d,po + letrozole 2.5mg/d,po * 18 weeks
Receives: Drug: Everolimus; Drug: Letrozole
Fluorouracil+epirubicin+cyclophosphamideActive comparatorFluorouracil 600mg/m2,iv,d1 + epirubicin 90mg/m2,iv,d1 + cyclophosphamide 600mg/m2,iv,d1 * 6 cycles (every 21 days per cycle)
Receives: Drug: Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

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

  1. Feasibility of the trial

    Measured: during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)

Secondary outcomes (11)

  1. Ultrasound response rate

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  2. Pathological complete response (pCR) rate

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  3. Breast-conserving surgery rate

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)

  5. Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  6. Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  7. Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  8. Peripheral blood NK cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  9. Blood tumor-specific CTLs count change in relation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  10. Peripheral blood CD4+ T cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

  11. Tumor Ki67 index change in ralation to neoadjuvant therapy

    Measured: at definitive surgery (18-20 weeks after the first dose of study medication)

Timeline

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

  1. First posted18 Apr 2016 (estimated)
  2. Study startJun 2016
  3. Primary completion14 Mar 2020
  4. Study completion14 Mar 2020

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02742051
Sponsor's protocol ID
50102016015
Status last verified
Sep 2021
First submitted
7 Apr 2016
Last updated
23 Sep 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Wu W, Chen J, Deng H, Jin L, He Z, Rao N, Nie Y, Yao Y, Yang Y, Su F, Liu J. Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: a randomized pilot trial. BMC Cancer. 2021 Jul 27;21(1):862. doi: 10.1186/s12885-021-08612-y.

    PubMed 34315439

  • Wu W, Deng H, Rao N, You N, Yang Y, Cao M, Liu J. Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: study protocol for a randomized pilot trial. Trials. 2017 Oct 25;18(1):497. doi: 10.1186/s13063-017-2228-5.

    PubMed 29070044

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus, Letrozole and Fluorouracil in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 15 inclusion and 8 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: finished, as of the sponsor's last update on 23 Sep 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the trial (time frame: during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)). 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 NCT02742051, which also lists 2 linked publications.

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 23 Sep 2021.

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