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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01822314




Registration number
NCT01822314
Ethics application status
Date submitted
25/03/2013
Date registered
2/04/2013
Date last updated
7/03/2024

Titles & IDs
Public title
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer
Scientific title
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer " ETNA (Evaluating Treatment With Neoadjuvant Abraxane)
Secondary ID [1] 0 0
2012-003481-41
Secondary ID [2] 0 0
FM-12-B01
Universal Trial Number (UTN)
Trial acronym
ETNA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abraxane
Treatment: Drugs - Paclitaxel

Active comparator: Paclitaxel - Paclitaxel will be given on week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles.

AC or EC or FEC will then be given on day 1 every 3 weeks for 4 cycles

Experimental: Abraxane - Abraxane will be given at the dosage of 125 mg/m2 on week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles.

AC or EC or FEC will then be given on day 1 every 3 weeks for 4 cycles


Treatment: Drugs: Abraxane
Abraxane at the dosage of 125 mg/m2 will be delivered over 30 minutes on week 1, 2 and 3 followed by 1 week rest. week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles

Treatment: Drugs: Paclitaxel
Paclitaxel at the dosage of 90 mg/m2 diluted in 250 mL of water for injection (WFI) over 1 hour given week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
pathologic Complete Response (pCR)
Timepoint [1] 0 0
At the time of surgery: 40 months after the randomization of the first patient
Secondary outcome [1] 0 0
clinical Overall Response (cOR)
Timepoint [1] 0 0
At the time of surgery: 40 months after the randomization of the first patient
Secondary outcome [2] 0 0
Event Free Survival (EFS)
Timepoint [2] 0 0
5 years after the first patient in and 10 years after randomization of last patient in
Secondary outcome [3] 0 0
Distant Event Free Survival (DEFS)
Timepoint [3] 0 0
5 years after the first patient in and 10 years after randomization of last patient in
Secondary outcome [4] 0 0
Local Event Free Survival
Timepoint [4] 0 0
5 years after the first patient in and 10 years after randomization of last patient in
Secondary outcome [5] 0 0
Regional Event Free Survival
Timepoint [5] 0 0
5 years after the first patient in and 10 years after randomization of last patient in
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
13 years from the date of first patient in
Secondary outcome [7] 0 0
Safety and Tolerability
Timepoint [7] 0 0
Each participant will be followed for the duration of treatment period, approximately 9 months

Eligibility
Key inclusion criteria
* Female patients aged 18 years or older
* Histologically confirmed invasive unilateral breast cancer
* HER2-negative disease
* Known hormone receptor status (estrogen receptor [ER], progesterone receptor [PgR]), tumor grade and, if institutional standard permits, known Ki67 value
* Available paraffin-embedded tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, hormone receptor status, Ki67 value and biomarker evaluation is mandatory
* One of the following clinical stages:
* T2, T3, T4 disease, triple negative (HER2, ER, PgR)
* T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumor grade (G II-III)
* ECOG performance status 0 or 1
* Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
* Willing and able to comply with the protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Synchronous contralateral breast cancer or presence of metastatic disease (M1). Exception: contralateral insitu ductal cancer
* Surgical axillary staging procedure prior to study entry. Exceptions: 1) Fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted
* Pregnant or lactating women.
* Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, for example abstinence, an intra-uterine device, or double barrier method of contraception
* Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
* Previous investigational treatment for any condition within 4 weeks of randomization date
* Patients on therapy with a strong CYP3A4 inhibitor and on therapy with Warfarin (Coumadin)
* Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible.
* Pre-existing motor or sensory neuropathy of grade > 1 for any reason
* Patients with a history of hypersensitivity due to drugs containing polyoxyethylene castor oil (Cremophor EL) (e.g., ciclosporin), or hardened castor oil (e.g., vitamin preparations for injection, etc.)
* Other serious illness or medical condition including: history of documented congestive cardiac failure; angina pectoris requiring anti-anginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
* Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs
* Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus
* Hematology and biochemistry tests within normla limits
* Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2023
Sample size
Target
Accrual to date
Final
632
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Peter McCallum Cancer Centre - East Melbourne
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre Department of Surgical Oncology - East Melbourne
Recruitment hospital [4] 0 0
Eastern Health Breast Cancer Research - Maroondah Breast Clinic - Ringwood East
Recruitment hospital [5] 0 0
Eastern Health Breast Cancer Research Maroondah Breast Clinic - Ringwood East
Recruitment hospital [6] 0 0
Mount Hospital - Breast Clinical Trials Unit - Perth
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
500 - Adelaide
Recruitment postcode(s) [3] 0 0
8006 - East Melbourne
Recruitment postcode(s) [4] 0 0
8600 - East Melbourne
Recruitment postcode(s) [5] 0 0
3135 - Ringwood East
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Augsburg
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Bochum
Country [4] 0 0
Germany
State/province [4] 0 0
Erlangen
Country [5] 0 0
Germany
State/province [5] 0 0
Frankfurt
Country [6] 0 0
Germany
State/province [6] 0 0
Hamburg
Country [7] 0 0
Germany
State/province [7] 0 0
Hannover
Country [8] 0 0
Germany
State/province [8] 0 0
Köln
Country [9] 0 0
Germany
State/province [9] 0 0
Munich
Country [10] 0 0
Germany
State/province [10] 0 0
Speyer
Country [11] 0 0
Italy
State/province [11] 0 0
BG
Country [12] 0 0
Italy
State/province [12] 0 0
BO
Country [13] 0 0
Italy
State/province [13] 0 0
Ferrara
Country [14] 0 0
Italy
State/province [14] 0 0
GE
Country [15] 0 0
Italy
State/province [15] 0 0
MB
Country [16] 0 0
Italy
State/province [16] 0 0
MI
Country [17] 0 0
Italy
State/province [17] 0 0
PD
Country [18] 0 0
Italy
State/province [18] 0 0
PV
Country [19] 0 0
Italy
State/province [19] 0 0
RE
Country [20] 0 0
Italy
State/province [20] 0 0
UD
Country [21] 0 0
Italy
State/province [21] 0 0
VI
Country [22] 0 0
Russian Federation
State/province [22] 0 0
St. Petersburg
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
Spain
State/province [24] 0 0
Aragon
Country [25] 0 0
Spain
State/province [25] 0 0
Baleares
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Tenerife
Country [29] 0 0
Spain
State/province [29] 0 0
A Coruña
Country [30] 0 0
Spain
State/province [30] 0 0
Alicante
Country [31] 0 0
Spain
State/province [31] 0 0
Badalona
Country [32] 0 0
Spain
State/province [32] 0 0
Caceres
Country [33] 0 0
Spain
State/province [33] 0 0
Córdoba
Country [34] 0 0
Spain
State/province [34] 0 0
Donostia
Country [35] 0 0
Spain
State/province [35] 0 0
Jaen
Country [36] 0 0
Spain
State/province [36] 0 0
La Coruna
Country [37] 0 0
Spain
State/province [37] 0 0
Lleida
Country [38] 0 0
Spain
State/province [38] 0 0
Murcia
Country [39] 0 0
Spain
State/province [39] 0 0
Salamanca
Country [40] 0 0
Spain
State/province [40] 0 0
San Sebastián
Country [41] 0 0
Spain
State/province [41] 0 0
Sevilla
Country [42] 0 0
Spain
State/province [42] 0 0
Toledo
Country [43] 0 0
Spain
State/province [43] 0 0
Valencia
Country [44] 0 0
Spain
State/province [44] 0 0
Ávila

Funding & Sponsors
Primary sponsor type
Other
Name
Fondazione Michelangelo
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luca Gianni, MD
Address 0 0
San Raffaele Hospital, Milan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01822314