Breast Cancer MetastaticAnastaseNCT05609903
Atezolizumab With Nab-paclitaxel for Patients With Triple-negative Stage IV Breast Cancer
An observational study of Breast Cancer Metastatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The study will evaluate the therapeutic efficacy of the association of Atezolizumab plus nabPaclitaxel in a real life context, in order to document any differences both in terms of activity and safety with respect to the knowledge of the association reported in the literature 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?
- Atezolizumab in combination with nab-paclitaxel
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2019to 31 May 2022
- Phase
- Observational
- 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
Study population: Women aged ≥ 18 with biopsy proven Triple Negative Breast Cancer locally advanced or stage IV at diagnosis.
Who may be able to join
- Women aged ≥ 18 years who have provided written informed consent
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- No prior chemotherapy, experimental or targeted systemic therapy for inoperable locally advanced or metastatic TNBC. Prior chemotherapy (including taxanes) in the neoadjuvant or adjuvant setting is allowable if treatment was completed ≥12 months prior to enter the compassionate use program
- PD-L1-positive tumour status defined as PD-L1 expression ≥1% on tumour-infiltrating immune cells as percentage per tumour area, assessed by the Ventana PD-L1 (SP142) assay based on the status of the primary tumor and/or the biopsy of metastatic disease before starting the treatment. Samples should be assessed by a qualified laboratory and different assays are not acceptable
- Patients eligible for ongoing atezolizumab clinical trials from which they may benefit are excluded
- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
Show all 30Show fewer
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)
- ANC ≥1500 cells/µL (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks prior to Cycle 1, Day 1);
- Lymphocyte count ≥500/µL; Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1);
- Hemoglobin ≥9.0 g/dL; AST, ALT, and alkaline phosphatase ≤2.5x the upper limit of normal (ULN), with the following exceptions:
- Patients with documented liver metastases: AST and ALT ≤5x ULN
- Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5x ULN
- Serum bilirubin ≤1.25x ULN (patients with known Gilbert disease who have serum bilirubin level ≤3x ULN may be enrolled)
- INR and aPTT ≤1.5x ULN (this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose)
- Calculated creatinine clearance ≥30 mL/min
- Absence of a positive test for HIV, active hepatitis B or hepatitis C, active tuberculosis
- Absence of significant cardiovascular disease (New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to treatment start, unstable arrhythmias, or unstable angina. Patients with a known left ventricular ejection fraction (LVEF) <40% will be excluded. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF <50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate)
- No known untreated, symptomatic or corticosteroid-dependent brain metastases
- Patients with any history of immune deficiencies or autoimmune disease are excluded from the treatment. Possible exceptions could be autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone, controlled type 1 diabetes mellitus on a stable insulin dosing regimen, eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only
- Patients must not be administered systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to start the treatment
- Patients must agree not to receive live, attenuated vaccine (e.g., FluMist®) within 28 days prior to the first dose of study treatment (Cycle 1, Day 1), during treatment, or within 5 months following the last dose of atezolizumab
- No known hypersensitivity or allergy to nab-paclitaxel, to any of the excipients, to biopharmaceuticals produced in Chinese hamster ovary cells, or to any component of the atezolizumab formulation
- Pregnancy or lactation are general medical exclusion criteria from the treatment
- Women of child bearing potential must agree to either use a contraceptive method with a failure rate of ≤ 1% per year or to remain abstinent (refrain from heterosexual intercourse) during the treatment period and for at least 5 months after the last dose of atezolizumab or 1 month after the last dose of nab-paclitaxel, whichever is later. For definition of postmenopausal status see the study protocol
- Women of child bearing potential must have a negative serum pregnancy test result prior to start the treatment
- Esclusion Criteria:
- Patients who have not completed 1 cycle of treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atezolizumab in Combination With Nab-paclitaxel for Patients With Previously Untreated Metastatic Triple-negative Breast Cancer in a Real World Experience
The study will evaluate the therapeutic efficacy of the association of Atezolizumab plus nabPaclitaxel in a real life context, in order to document any differences both in terms of activity and safety with respect to the knowledge of the association reported in the literature
Read the detailed description
On 8thMarch 8 2019, the Food and Drug Administration (FDA) granted accelerated approval to Atezolizumab in combination with nab-paclitaxel for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area). FDA also approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic device for selecting TNBC patients for atezolizumab. Approval was based on the clinical trial IMpassion130 results.
In EU, the Committee for Medicinal Products for Human Use (CHMP) issued positive opinion on 27thJune 2019 for the use of Atezolizumab 840 mg in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. Hereafter, the European Commission approved Atezolizumab for the treatment of mTNBC in August 2019.
In some cases, free access to pharmaceutical treatment is allowed in Italy before AIFA authorises its marketing or, for medicines already authorised, for indications other than those for which the medicinal product has been authorised in Italy (off-label use). One route for early access to a medicinal product is Compassionate use that involves direct and free delivery of the medicine by the manufacturer.
Due to the severity of the disease and the lack of further valid therapeutic alternatives, Roche S.p.A. in accordance with AIFA opened a Compassionate Use Program (CUP) based on the European indication mentioned above on 18th November 2019. The Program closed on 28th August 2020 following the approval and reimbursement granted by AIFA to Atezolizumab in mTNBC.
To date the drug is therefore available and reimbursed by the national health system, and has become part of daily clinical practice, as also indicated by the most recent AIOM guidelines.
Randomized controlled trials (RCTs) are trials in selected patients, they have a high internal validity but low external validity, their results could not extend to real word patient with different characteristics (patients in more severe or less severe clinical conditions, protected bands), there are a few data on interactions with concomitant diseases and therapies and on actual compliances with other therapies.
Real world evidence is important as it complements data from RCTs. After the pivotal trial, it is essential to continue studying the risk-benefit profile of the combination and therefore it is necessary carry out real world experience.
In the context of Compassionate Use Program a hundred patients have been treated with Atezolizumab plus nab-paclitaxel throughout Italy and it would be scientifically interesting to collect their data retrospectively as the first source of efficacy and safety of this combination in a real population.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Atezolizumab in combination with nab-paclitaxel
- Keywords
- Atezolizumab; Nab-Paclitaxel, Metastatic 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.
Atezolizumab in combination with nab-paclitaxelDrug
Treatment of patients with stage IV triple negative breast cancer with Atezolizumab in combination with nab-paclitaxel
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective responce rate
Rate of patients with a partial responce or stable disease
Measured: 1 year
Time-to-treatment discontinuation
Time from tha start of therapy to the time of treatment discontinuation for any reason
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Nov 2019
- Primary completion1 Aug 2020
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FABI ALESSANDRA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Alessandra Fabi, Principal investigator, Policlinico A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609903
- Sponsor's protocol ID
- ID4060
- Acronym
- Anastase
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atezolizumab in Combination With Nab-paclitaxel for Patients With Previously Untreated Metastatic Triple-negative Breast Cancer in a Real World Experience
- ClinicalTrials.gov ID
- NCT05609903
- Acronym / sponsor ID
- Anastase / ID4060
- Conditions
- Breast Cancer Metastatic
- Keywords
- Atezolizumab; Nab-Paclitaxel, Metastatic Breast Cancer;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Nov 2022 (actual)
- 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.
The study will evaluate the therapeutic efficacy of the association of Atezolizumab plus nabPaclitaxel in a real life context, in order to document any differences both in terms of activity and safety with respect to the knowledge of the association reported in the literature
Detailed description
On 8thMarch 8 2019, the Food and Drug Administration (FDA) granted accelerated approval to Atezolizumab in combination with nab-paclitaxel for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area). FDA also approved the Ventana PD-L1 (SP142) Assay as a companion diagnostic device for selecting TNBC patients for atezolizumab. Approval was based on the clinical trial IMpassion130 results.
In EU, the Committee for Medicinal Products for Human Use (CHMP) issued positive opinion on 27thJune 2019 for the use of Atezolizumab 840 mg in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease. Hereafter, the European Commission approved Atezolizumab for the treatment of mTNBC in August 2019.
In some cases, free access to pharmaceutical treatment is allowed in Italy before AIFA authorises its marketing or, for medicines already authorised, for indications other than those for which the medicinal product has been authorised in Italy (off-label use). One route for early access to a medicinal product is Compassionate use that involves direct and free delivery of the medicine by the manufacturer.
Due to the severity of the disease and the lack of further valid therapeutic alternatives, Roche S.p.A. in accordance with AIFA opened a Compassionate Use Program (CUP) based on the European indication mentioned above on 18th November 2019. The Program closed on 28th August 2020 following the approval and reimbursement granted by AIFA to Atezolizumab in mTNBC.
To date the drug is therefore available and reimbursed by the national health system, and has become part of daily clinical practice, as also indicated by the most recent AIOM guidelines.
Randomized controlled trials (RCTs) are trials in selected patients, they have a high internal validity but low external validity, their results could not extend to real word patient with different characteristics (patients in more severe or less severe clinical conditions, protected bands), there are a few data on interactions with concomitant diseases and therapies and on actual compliances with other therapies.
Real world evidence is important as it complements data from RCTs. After the pivotal trial, it is essential to continue studying the risk-benefit profile of the combination and therefore it is necessary carry out real world experience.
In the context of Compassionate Use Program a hundred patients have been treated with Atezolizumab plus nab-paclitaxel throughout Italy and it would be scientifically interesting to collect their data retrospectively as the first source of efficacy and safety of this combination in a real population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged ≥ 18 with biopsy proven Triple Negative Breast Cancer locally advanced or stage IV at diagnosis.
Key inclusion criteria (30 listed)
- Women aged ≥ 18 years who have provided written informed consent
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- No prior chemotherapy, experimental or targeted systemic therapy for inoperable locally advanced or metastatic TNBC. Prior chemotherapy (including taxanes) in the neoadjuvant or adjuvant setting is allowable if treatment was completed ≥12 months prior to enter the compassionate use program
- PD-L1-positive tumour status defined as PD-L1 expression ≥1% on tumour-infiltrating immune cells as percentage per tumour area, assessed by the Ventana PD-L1 (SP142) assay based on the status of the primary tumor and/or the biopsy of metastatic disease before starting the treatment. Samples should be assessed by a qualified laboratory and different assays are not acceptable
- Patients eligible for ongoing atezolizumab clinical trials from which they may benefit are excluded
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Atezolizumab in combination with nab-paclitaxelTreatment of patients with stage IV triple negative breast cancer with Atezolizumab in combination with nab-paclitaxel | Drug | – |
Primary outcome
Objective responce rate
Time frame: 1 year
Rate of patients with a partial responce or stable disease
Time-to-treatment discontinuation
Time frame: 1 year
Time from tha start of therapy to the time of treatment discontinuation for any reason
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 8 Nov 2022.
- 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.
Alessandra Fabi principal investigator
Policlinico A. Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 30 inclusion and 0 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 8 Nov 2022. 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 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.
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?
Objective responce rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2022.