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Breast CancerPhase 2TREndNCT02549430

To Reverse ENDocrine Resistance Trial - PD 0332991 Monotherapy vs PD 0332991 in Combination With the Endocrine Therapy

A Phase 2 study testing Palbociclib, Anastrozole and Letrozole in people with Breast Cancer, run by Fondazione Sandro Pitigliani at 6 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

This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Palbociclib, Anastrozole and Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
6 sitesItaly
Study dates
Oct 2012to 9 Feb 2017
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of adenocarcinoma of the breast with evidence of metastatic disease
  • ER positive tumor ≥ 10%
  • HER2 negative breast cancer by FISH or IHC
  • Progression of advanced breast cancer on first or second line endocrine therapy for advanced breast cancer
  • Paraffin-embedded tumor available for centralized assessment of biomarkers
  • Measurable disease according to RECIST 1.1 (bone only disease is allowed only if measurable).
Show all 10Show fewer
  • Postmenopausal status
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0 -2
  • Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade >1
  • Adequate organ function

Who cannot join

  • Unstable brain metastases
  • Prior treatment with more than one line of CT or more than two lines of HT advanced breast cancer or any CDK inhibitor
  • Current treatment with therapeutic doses of anticoagulant
  • Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors / inducers, drugs that are predominantly metabolized by CYP3A with narrow therapeutic indices, drugs with the potential of prolonging QT interval
  • Diagnosis of any secondary malignancy within the last 3 years
  • Active inflammatory bowel disease or chronic diarrhea
  • Known human immunodeficiency virus infection; active hepatitis C, active hepatitis B

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Italy6 sites

  • Azienda Ospedaliera Papa Giovanni Xxiii

    Bergamo, 24127

  • Ospedale Antonio Perrino

    Brindisi, 72100

  • Istituto Europeo Oncologia

    Milan, 20141

  • A.O.U. Federico Ii Di Napoli

    Naples, 80131

  • Fondazione Maugeri

    Pavia, 27100

  • A.O.U. S. Maria Della Misericordia Di Udine

    Udine, 33100

Other trials in Italy

About this study

Official title: Phase 2,Open-label,Multicenter,Randomized Study of PD0332991 (Oral CDK4/6 Inhibitor) Monotherapy and in Combination With the HT to Which the pt Has Progressed in the Previous Line for ER+,Her2- Post-menopausal Advanced Breast Cancer Pts

This study aims to assess the activity of PD0332991 in monotherapy and in combination with the endocrine therapy (anastrozole, letrozole, exemestane or fulvestrant) on which the patient has progressed in the previous line for advanced breast cancer in order to reverse endocrine resistance.

Read the detailed description

In a clinical context, there is a lack of molecular compounds with demonstrated clinical activity in delaying/reversing resistance to endocrine agents. CDK 4/6 inhibitors may represent a biologically-driven option in this context.

With the present study investigators aim to complement the ongoing trial on PD0332991 by acquiring information on its clinical activity in post-menopausal patients with ER positive, Her2 negative advanced breast cancer patients already pretreated with a first-line or second line endocrine therapy.

Conditions
Breast Cancer
Being tested
Palbociclib, Anastrozole, Letrozole, Exemestane, Fulvestrant
Keywords
Advanced breast cancer, Postmenopausal, ER positive, Her2 negative
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PalbociclibDrug

    Also called PD0332991

    Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off)

  • AnastrozoleDrug

    Continuation of prior anastrozole 1mg/day orally in a continuous regimen

  • LetrozoleDrug

    Continuation of prior letrozole 2.5mg/day orally in a continuous regimen

  • ExemestaneDrug

    Continuation of prior exemestane 25mg/day orally in a continuous regimen

  • FulvestrantDrug

    Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen

Study groups in NCT02549430
Study groupRoleWhat they receive
Arm AExperimentalPalbociclib monoterapy
Receives: Drug: Palbociclib
Arm BExperimentalPalbociclib + HT (Anastrozole, Letrozole, Exemestane, Fulvestrant)
Receives: Drug: Palbociclib; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Fulvestrant

What is being measured

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

  1. Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit)

    All randomized patients with adequate baseline disease assessment with measurable disease, the disease under study and who start treatment on the assigned arm will be considered evaluable for clinical benefit (CB). The probability of CB on each randomized treatment arm will be estimated by dividing the number of patients with CB by the number of evaluable patients randomized to the treatment arm.

    Measured: Baseline up to 3 years

Secondary outcomes (5)

  1. Progression free survival (PFS)

    PFS is the time from randomization date to date of first documentation of progression or death due to any cause, whichever occurs first. Documentation of progression must be by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. All patients randomized will be considered evaluable for PFS.

    Measured: Baseline up to 3 years

  2. Objective Response (OR)

    All randomized patients with adequate baseline disease assessment with measurable disease, the disease under study and who start treatment on the assigned arm will be considered evaluable for objective response (CR or PR). The probability of OR on each randomized treatment arm will be estimated by dividing the number of patients with OR by the number of evaluable patients randomized to the respective treatment arm ("response rate").

    Measured: Baseline up to 3 years

  3. Overall Survival (OS)

    OS is the time from randomization date to date of death due to any cause. All patients randomized will be considered evaluable for OS.

    Measured: Baseline up to 6 years

  4. Time to Progression (TTP)

    TTP is the time from randomization date to date of first documentation of objective progression. All patients randomized will be considered evaluable for TTP.

    Measured: Baseline up to 3 years

  5. Duration of Response (DR)

    For patients with an objective response (CR or PR), duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR will be based on investigator assessment of response.

    Measured: Baseline up to 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 posted15 Sep 2015 (estimated)
  2. Study startOct 2012
  3. Primary completion9 Feb 2017
  4. Study completion9 Feb 2017

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
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02549430
Sponsor's protocol ID
TREnd
Other IDs
2011-005637-38
Acronym
TREnd
Status last verified
Jul 2017
First submitted
27 Aug 2015
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Galardi F, De Luca F, Biagioni C, Migliaccio I, Curigliano G, Minisini AM, Bonechi M, Moretti E, Risi E, McCartney A, Benelli M, Romagnoli D, Cappadona S, Gabellini S, Guarducci C, Conti V, Biganzoli L, Di Leo A, Malorni L. Circulating tumor cells and palbociclib treatment in patients with ER-positive, HER2-negative advanced breast cancer: results from a translational sub-study of the TREnd trial. Breast Cancer Res. 2021 Mar 24;23(1):38. doi: 10.1186/s13058-021-01415-w.

    PubMed 33761970

  • Malorni L, Curigliano G, Minisini AM, Cinieri S, Tondini CA, D'Hollander K, Arpino G, Bernardo A, Martignetti A, Criscitiello C, Puglisi F, Pestrin M, Sanna G, Moretti E, Risi E, Biagioni C, McCartney A, Boni L, Buyse M, Migliaccio I, Biganzoli L, Di Leo A. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial. Ann Oncol. 2018 Aug 1;29(8):1748-1754. doi: 10.1093/annonc/mdy214.

    PubMed 29893790

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib, Anastrozole and Letrozole in people with Breast Cancer, run by Fondazione Sandro Pitigliani at 6 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 10 inclusion and 7 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

Incidence of complete response (CR), partial response (PR) or stable disease (SD) ≥24 weeks (clinical benefit) (time frame: Baseline up to 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 NCT02549430, 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 1 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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