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Breast Cancer MetastaticPhase 3MAIN-ANCT02511639

Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients

A Phase 3 study testing Everolimus and Aromatase Inhibitors in people with Breast Cancer Metastatic, run by Istituto Oncologico Veneto IRCCS at 16 sites in Italy.

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

The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Metastatic
What is being tested?
Everolimus and Aromatase Inhibitors
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
16 sitesItaly
Study dates
30 Jul 2014to 31 Jul 2020
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years old women with metastatic breast cancer
  • Histological confirmation of hormone-receptor positive (defined as at least 10% of estrogen receptor (ER) and/or progesterone receptor (PgR) positivity) and human epidermal growth factor receptor 2 (HER2) negative (score 0-1+ in immunohistochemistry or FISH negativity) breast cancer
  • Postmenopausal status
  • One line of chemotherapy for metastatic disease; patients must have received a minimum of 6 cycles of chemotherapy in order to be eligible, and must have obtained disease control (CR or PR od SD)
  • Eastern Cooperative Oncology Group (ECOG) Performance status < 2
  • Adequate bone marrow and coagulation function
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  • Adequate liver function
  • Adequate renal function
  • Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × upper limit of normal (ULN). In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved
  • Fasting glucose < 1.5 × ULN
  • Written informed consent obtained before any screening procedure and according to local guidelines.

Who cannot join

  • HER2-overexpressing patients by local laboratory testing (immunohistochemistry 3+ staining or in situ hybridization positive)
  • Previous treatment with mammalian target of rapamycin (mTOR) inhibitors
  • Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin)
  • More than one chemotherapy line for metastatic disease
  • Treatment with angiogenetic compounds as maintenance therapy (eg. bevacizumab)
  • Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment
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  • Symptomatic central nervous system metastases
  • Patients with a known history of HIV positivity
  • Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the international normalized ratio (INR) is ≤ 2.0)
  • Any severe and / or uncontrolled medical conditions such as:
  • Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN
  • Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
  • Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of lung for carbon monoxide (DLco) and O2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.
  • Patients who test positive for hepatitis B or C (patients who test negative for hepatitis B virus (HBV)-DNA, HBsAg, and HBcAb but positive for HBsAb with prior history of vaccination against Hepatitis B will be eligible)
  • Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme Cytochrome P3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritonavir, Telithromycin) within the last 5 days prior to enrollment
  • History of non-compliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

    Ancona, AN, 60020

  • Ospedale Papa Giovanni XXIII

    Bergamo, Bg

  • Policlinico Sant'Orsola Malpighi

    Bologna, BO, 40138

  • Azienda Spedali Civili di Brescia

    Brescia, BS, 25123

  • ASL Brindisi "Antonio Perrini"

    Brindisi, BR, 72100

  • Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

    Catania, CT, 95123

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

    Cona, FE, 44124

  • A.S.O. S.Croce e Carle di Cuneo

    Cuneo, CN, 12100

  • Ospedale Misericordia di Grosseto

    Grosseto, GR, 58100

  • Ospedale dell'Angelo

    Mestre, 30174

  • Istituto Nazionale dei Tumori IRCCS

    Milan, MI, 20133

  • Ospedale Sacro Cuore - Don Calabria

    Negrar, VR, 37042

  • Azienda Ospedaliera Universitaria di Parma

    Parma, PR, 43126

  • IRCCS - Azienda Ospedaliera S.M. Nuova

    Reggio Emilia, RE, 42123

  • Ospedale Civile Santa Chiara

    Trento, TN

  • Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

    Udine, UD, 33100

Other trials in Italy

About this study

Official title: MAINtenance Afinitor: A Randomized Trial Comparing Maintenance Aromatase Inhibitors (AIs) + Everolimus (Afinitor) vs AIs in Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients With Disease Control After First Line Chemotherapy

The purpose of this study is to compare maintenance Aromatase Inhibitors (AIs) + everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR+ metastatic breast cancer.

Read the detailed description

The purpose of this study is:

  • to compare the progression free survival (PFS) of AIs/everolimus to AIs administered as maintenance therapy in HR+ advanced breast cancer patients with disease control (Complete Response (CR), Partial Response (PR) or Stable Disease (SD))after 1st line chemotherapy.
  • To evaluate the overall survival
  • To assess the safety profile
  • To evaluate the response rate
Being tested
Everolimus, Aromatase Inhibitors
Keywords
Hormone receptor positive, HER2 negative

What participants receive

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

  • EverolimusDrug

    Everolimus is formulated as tablets of 10 mg strength for oral administration.

  • Aromatase InhibitorsDrug

    Also called Exemestane, Letrozole, Anastrozole

    Anastrozole is formulated as tablets of 1 mg strength for oral administration. Letrozole is formulated as tablets of 2.5 mg strength for oral administration. Exemestane is formulated as tablets of 25 mg strength for oral administration.

Study groups in NCT02511639
Study groupRoleWhat they receive
Arm A: Everolimus & Aromatase inhibitorsExperimentalEverolimus 10 mg po daily + Aromatase inhibitors (Exemestane 25 mg po daily or Letrozole 2.5 mg po daily or Anastrozole 1 mg po daily)
Receives: Drug: Everolimus; Drug: Aromatase Inhibitors
Arm B: Aromatase inhibitorsActive comparatorAromatase inhibitors (Exemestane 25 mg po daily or Letrozole 2.5 mg po daily or Anastrozole 1 mg po daily)
Receives: Drug: Aromatase Inhibitors

What is being measured

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

  1. Progression free survival

    PFS is defined as the time from randomization to the first documentation of objective disease progression or death from any cause

    Measured: Up to 2 years after randomisation

Secondary outcomes (3)

  1. Overall survival

    Overall survival is defined as the interval between the date of randomization and the date of patient death due to any cause, or the last date the patient was known to be alive

    Measured: Up to 2 years after randomisation

  2. Response rate

    Responses will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria only for patients with measurable disease at the time of study entry.

    Measured: Every 12 weeks during treatment, up to 2 years after randomisation

  3. Safety profile

    Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI -CTCAE), version 4.

    Measured: Baseline and every 4 weeks during treatment, up to 2 years after randomisation

Timeline

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

  1. First posted30 Jul 2015 (estimated)
  2. Study start30 Jul 2014
  3. Primary completion28 Feb 2020
  4. Study completion31 Jul 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02511639
Sponsor's protocol ID
CRAD001JIT36T
Other IDs
2013-004153-24
Acronym
MAIN-A
Status last verified
Dec 2020
First submitted
16 Jul 2015
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus and Aromatase Inhibitors in people with Breast Cancer Metastatic, run by Istituto Oncologico Veneto IRCCS at 16 sites in Italy.

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 11 inclusion and 19 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. 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?

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?

Progression free survival (time frame: Up to 2 years after randomisation). 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 NCT02511639.

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 3 Dec 2020.

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