Metastatic BreastcancerPhase 2SNAPNCT01746225

Schedules of Nab-Paclitaxel in Metastatic Breast Cancer

A Phase 2 study testing nab-Paclitaxel in people with Metastatic Breastcancer, run by ETOP IBCSG Partners Foundation at 41 sites in 6 countries.

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breastcancer
What is being tested?: nab-Paclitaxel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 258 participants
Where: 41 sitesin 6 countries
Study dates: Apr 2013to 16 Mar 2023
Phase: Phase 2

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 or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
Female aged 18 years or older.
Life expectancy > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.

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If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
Normal hematologic status.
Normal renal function.
Normal liver function.
Normal cardiac function.
Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
Completed baseline Quality of Life Form.
The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.

Who cannot join

Any prior chemotherapy for metastatic breast cancer.
Presence of central nervous system (CNS) metastasis.
Peripheral neuropathy grade 2 or higher (CTCAE version 4).
Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
Pregnant or lactating.
Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).

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Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Contraindications or known hypersensitivity to the study medication or excipients.
The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.

Trial locations and contacts

41 sites in 6 countries.

Country

City, postcode or hospital

41 sites in 6 countries

Italy11 sites

Azienda Ospedaliera SS Antonio e Biagio
Alessandria, 15121
Ospedale degli Infermi
Biella, 13900
IRCCS MultiMedica
Castellanza, 21053
E.O. Ospedali Galliera
Genova, 16128
Istituto Europeo di Oncologia (IEO)
Milan
Uo Medicina Ocologica Ospedale Di Carpri e Mirandola, Azienda USL di Modena
Modena, 41012
Fondazione Salvatore Maugeri
Pavia, 27100
U.O. Oncologia, AUSL Rimini
Rimini, 47923
Universita degli Studi di Roma La Sapienza
Roma, 00161
Azienda Osp. Universitaria di Udine
Udine, 33100
Ospedale di Circolo e Fondatione Macchi
Varese, 21100

Other trials in Italy

Switzerland11 sites

Kantonsspital Aarau
Aarau, 5001
Universitätsspital Basel
Basel, 4031
Instituto Oncologico della Svizzera Italiana
Bellinzona, 6500
Universitätsspital/ Inselspital Bern
Bern, 3011
Spitalzentrum Biel
Biel, 2501
Kantonsspital Graubünden
Chur, 7000
Kantonsspital Baselland
Liestal, 4410
Luzerner Kantonsspital
Lucerne, 6000
Kantonsspital St. Gallen
Sankt Gallen, 9007
Onkologiezentrum Thun-Berner Oberland
Thun, 3600
Kantonsspital Winterthur
Winterthur, 8401

Other trials in Switzerland

Ireland10 sites

Bon Secours
Cork
Cork University Hospital
Cork
Beaumont Hospital
Dublin
Mater Misericordiae University Hospital
Dublin
Mater Private Hospital
Dublin
St James's Hospital
Dublin
St Vincent's University Hospital
Dublin
University Hospital Galway
Galway
Mid-Western Regional Hospital
Limerick
Waterford Regional Hospital
Waterford

Other trials in Ireland

Spain5 sites

Hospital Universitari Vall D'Hebron
Barcelona
Consorcop Hospitalario Provincial De Castellon
Castelló, 12002
Hospital Universitari Arnau De Vilanova De Lleida
Lleida, 25198
Hospital Universitari Sant Joan De Reus
Tarragona, 43204
Hospital Universitario Lozano Blesa De Zaragoza
Zaragoza, 50009

Other trials in Spain

Belgium3 sites

CHR de la Citadelle, Oncology-Haematology Unit
Liège, 4000
CHU Sart Tilman, Medical Oncology
Liège, 4000
Centre Hospitalier Peltzer-La Tourelle, Department of Clinical Cancerology
Verviers, 4800

Other trials in Belgium

Slovenia1 site

Institute of Oncology
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Randomized Phase II Study Evaluating Different Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP Trial)

Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting.

The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy.

The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.

Conditions: Metastatic Breastcancer
Being tested: nab-Paclitaxel
Keywords: Metastatic, Breast, Cancer, HER2-negative Stage IV, No previous chemotherapy
Medical subject headings: Neoplasm Metastasis, 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
Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

Study groups in NCT01746225
Study group	Role	What they receive
A: nab-Paclitaxel 150 mg/m2 days 1,15	Experimental	Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². Receives: Drug: nab-Paclitaxel
B: nab-Paclitaxel 100 mg/m2 days 1,8,15	Experimental	Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². Receives: Drug: nab-Paclitaxel
C: nab-Paclitaxel 75 mg/m2 days 1,8,15,22	Experimental	Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity. *Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m². Receives: Drug: nab-Paclitaxel

What is being measured

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

Progression-free Survival
Time from randomization until objective disease progression [progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event.
Measured: Reported after 18.2 months median follow-up since randomization

Secondary outcomes (5)

Feasibility of Treatment: Number of Participants Completed Treatment According to the Protocol for at Least 24 Weeks
Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing.
Measured: Baseline to 24 weeks follow-up
Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks
Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria [Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.]
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Best Overall Response
Best response according to RECIST 1.1 criteria [assessed by MRI] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Overall Survival
Time from randomization until death from any cause, or censored at date last known alive
Measured: Reported after 18.2 months median follow-up since randomization
Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6)
Primary quality of life=physical well being; endpoint based on the GLQ 8. The indicator was in Linear Analogue Self-Assessment (LASA) format ranging 0-100 (0=as bad as it can be, 100=as good as it can be).
Measured: Assessed from day 1 of cycle 4 through day 1 of cycle 12

Timeline

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

Apr 201316 Mar 2023

First posted10 Dec 2012 (estimated)
Study startApr 2013
Primary completionMay 2016
Study completion16 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Metastatic BreastcancerStudies 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: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01746225
Sponsor's protocol ID: IBCSG 42-12 / BIG 2-12
Other IDs: 2012-003058-10
Acronym: SNAP
Status last verified: May 2023
First submitted: 28 Nov 2012
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chia SK, Speers CH, D'yachkova Y, Kang A, Malfair-Taylor S, Barnett J, Coldman A, Gelmon KA, O'reilly SE, Olivotto IA. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer. 2007 Sep 1;110(5):973-9. doi: 10.1002/cncr.22867.
PubMed 17647245
Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005 Oct 15;104(8):1742-50. doi: 10.1002/cncr.21359.
PubMed 16149088
Andre F, Slimane K, Bachelot T, Dunant A, Namer M, Barrelier A, Kabbaj O, Spano JP, Marsiglia H, Rouzier R, Delaloge S, Spielmann M. Breast cancer with synchronous metastases: trends in survival during a 14-year period. J Clin Oncol. 2004 Aug 15;22(16):3302-8. doi: 10.1200/JCO.2004.08.095.
PubMed 15310773
Dawood S, Broglio K, Gonzalez-Angulo AM, Buzdar AU, Hortobagyi GN, Giordano SH. Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol. 2008 Oct 20;26(30):4891-8. doi: 10.1200/JCO.2007.14.1168. Epub 2008 Aug 25.
PubMed 18725649
Gennari A, Sun Z, Hasler-Strub U, Colleoni M, Kennedy MJ, Von Moos R, Cortes J, Vidal MJ, Hennessy B, Walshe J, Parraga KA, Ribi K, Bernhard J, Murillo SM, Pagani O, Barbeaux A, Borstnar S, Rabaglio-Poretti M, Maibach R, Regan MM, Jerusalem G; International Breast Cancer Study Group, Cancer Trials Ireland and SOLTI Group. A randomized phase II study evaluating different maintenance schedules of nab-paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Ann Oncol. 2018 Mar 1;29(3):661-668. doi: 10.1093/annonc/mdx772.
PubMed 29228091

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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