Breast CancerPhase 2EFFECTNCT02783222
EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer
A Phase 2 study testing Nab-paclitaxel in people with Breast Cancer, run by Fondazione Sandro Pitigliani at 14 sites in Italy.
Trial summary
This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 14 sitesItaly
- Study dates
- 30 Jan 2013to Dec 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
- Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria
- ECOG performance status 0-2
- Estimated life expectancy of ≥ 12 weeks
- No known active/symptomatic CNS metastases
- No previous chemotherapy for breast cancer in the advanced setting
- Adequate organ function including ( Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Bilirubin ≤ 1.5 mg/dL; ALT and AST ≤ 3 x ULN (with or without known hepatic metastases); ALP ≤ 2.5 x ULN; Serum creatinine ≤ 1.5 ULN or calculated creatinine clearance (CrCl) ≥ 50mL/min according to the Cockcroft Gault formula
- Written informed consent (according to ICH/GCP and national/local regulations)
Who cannot join
- Significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria)
- Clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
- Other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
- Intake of any concomitant medications or therapies that may potentially interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
- Presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
A.O.U. Ospedali Riuniti
Ancona, 60100
Centro Di Riferimento Oncologico
Aviano, 33081
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, 24127
Spedali Civili Brescia
Brescia, 25125
Ospedale Antonio Perrino
Brindisi, 72100
Ospedale Ss. Trinita'
Frosinone, 09039
Ospedale Vito Fazzi
Lecce, 73100
Ausl 12 Viareggio
Lucca, 50053
Istituto Europeo Oncologia
Milan, 20141
A.O.U. Federico Ii Di Napoli
Naples, 80131
Istituto Oncologico Veneto
Padova, 35128
Fondazione Maugeri
Pavia, 27100
A.O.U. S. Maria Della Misericordia Di Udine
Udine, 33100
Ospedale Civile Maggiore
Verona, 37126
About this study
Official title: EFFECT: A Randomized Phase II Study to Evaluate the EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly Patients With advanCed breasT Cancer
This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.
Read the detailed description
This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.
- Conditions
- Breast Cancer
- Being tested
- Nab-paclitaxel
- Keywords
- breast cancer, elderly patients
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Abraxane
comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Active comparator | Nab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks Receives: Drug: Nab-paclitaxel |
| Arm A | Experimental | Nab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Event is defined as either disease progression or death, or functional decline. Functional decline is defined as decreased in at least 1 point from baseline ADL, and/or IADL, as confirmed by the investigator as treatment-related and confirmed at the subsequent cycle
Measured: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient).
Secondary outcomes (5)
Objective response rate (ORR)
Documentation of disease response or progression will be based on RECIST 1.1 criteria
Measured: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient).
Clinical benefit rate (CBR)
Documentation of disease response or progression will be based on RECIST 1.1 criteria
Measured: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient)
Progression free survival (PFS)
Documentation of disease progression will be based on RECIST 1.1 criteria
Measured: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient)
Overall survival (OS)
Documentation of death
Measured: Every 12 weeks until death or trial completion (12 months after randomization of the last patient)
Incidence of adverse events
Severity will be reported based on CTCAE v4.0
Measured: Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start30 Jan 2013
- Primary completion22 Sep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Sandro Pitigliani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Biganzoli, MD, Principal investigator, Azienda USL Toscana Centro - Prato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783222
- Sponsor's protocol ID
- EFFECT
- Other IDs
- 2012-002707-18
- Acronym
- EFFECT
- Status last verified
- Jan 2018
- First submitted
- 28 Apr 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Biganzoli L, Cinieri S, Berardi R, Pedersini R, McCartney A, Minisini AM, Caremoli ER, Spazzapan S, Magnolfi E, Brunello A, Risi E, Palumbo R, Leo S, Colleoni M, Donati S, De Placido S, Orlando L, Pistelli M, Parolin V, Mislang A, Becheri D, Puglisi F, Sanna G, Zafarana E, Boni L, Mottino G. EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer. Breast Cancer Res. 2020 Aug 5;22(1):83. doi: 10.1186/s13058-020-01319-1.
PubMed 32758299
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT: A Randomized Phase II Study to Evaluate the EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly Patients With advanCed breasT Cancer
- ClinicalTrials.gov ID
- NCT02783222
- Acronym / sponsor ID
- EFFECT / EFFECT
- Conditions
- Breast Cancer
- Keywords
- breast cancer, elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fondazione Sandro PitiglianiUniversity, hospital or other
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.
Detailed description
This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B | Active comparator | Drug: Nab-paclitaxelNab-paclitaxel 125 mg/mq weekly for 3 out of every 4 weeks |
| Arm A | Experimental | Drug: Nab-paclitaxelNab-paclitaxel 100 mg/mq weekly for 3 out of every 4 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
- Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria
- ECOG performance status 0-2
- Estimated life expectancy of ≥ 12 weeks
- No known active/symptomatic CNS metastases
Key exclusion criteria (5 listed)
- Significant peripheral neuropathy (significant peripheral neuropathy is defined as ≥ grade 2 on CTCAE v4.0 criteria)
- Clinically significant comorbidities including: uncontrolled cardiac arrhythmias (except rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
- Other malignancy within the last 5 years, except for adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
- Intake of any concomitant medications or therapies that may potentially interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
- Presence of any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before trial registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxelAlso: Abraxanecomparison of different dosages of drug | Drug | Arm A, Arm B |
Primary outcome
Event-free survival (EFS)
Time frame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient).
Event is defined as either disease progression or death, or functional decline. Functional decline is defined as decreased in at least 1 point from baseline ADL, and/or IADL, as confirmed by the investigator as treatment-related and confirmed at the subsequent cycle
5 secondary outcomes
Objective response rate (ORR)
Time frame: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient).
Clinical benefit rate (CBR)
Time frame: Every 12 weeks, until disease progression or trial completion (12 months after randomization of the last patient)
Progression free survival (PFS)
Time frame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient)
Overall survival (OS)
Time frame: Every 12 weeks until death or trial completion (12 months after randomization of the last patient)
Incidence of adverse events
Time frame: Every 12 weeks until event occurrence or trial completion (12 months after randomization of the last patient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Derived from this study: PubMed 32758299Biganzoli L, Cinieri S, Berardi R, Pedersini R, McCartney A, Minisini AM, Caremoli ER, Spazzapan S, Magnolfi E, Brunello A, Risi E, Palumbo R, Leo S, Colleoni M, Donati S, De Placido S, Orlando L, Pistelli M, Parolin V, Mislang A, Becheri D, Puglisi F, Sanna G, Zafarana E, Boni L, Mottino G. EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer. Breast Cancer Res. 2020 Aug 5;22(1):83. doi: 10.1186/s13058-020-01319-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Biganzoli, MD principal investigator
Azienda USL Toscana Centro - Prato
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel in people with Breast Cancer, run by Fondazione Sandro Pitigliani at 14 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 8 inclusion and 5 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Event-free survival (EFS) (time frame: Every 12 weeks, until disease progression or death or trial completion (12 months after randomization of the last patient).). 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 NCT02783222, which also lists 1 linked publication.
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 10 Jan 2018.