Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01830244




Registration number
NCT01830244
Ethics application status
Date submitted
27/03/2013
Date registered
12/04/2013
Date last updated
2/07/2017

Titles & IDs
Public title
IST Neoadjuvant Abraxane in Newly Diagnosed Breast Cancer
Scientific title
Tailored Neoadjuvant Epirubicin and Cyclophosphamide (EC) and Nanoparticle Albumin Bound (Nab) Paclitaxel for Newly Diagnosed Breast Cancer
Secondary ID [1] 0 0
ALCC12.01
Universal Trial Number (UTN)
Trial acronym
Neonab
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 - Nab-Paclitaxel

Experimental: Nab-Paclitaxel 125mg/m2 - Epirubicin 90 mg/m2 and cyclophosphamide 600mg/m2 IV every 3 weeks for 4 cycles.
Nab paclitaxel 125mg/m2 IV days 1, 8 and 15 for 12 weeks In case of HER2 positive tumour patients will receive trastuzumab in combination with nab-Paclitaxel


Treatment: Drugs: Nab-Paclitaxel
Nab-Paclitaxel- 125 mg/m2 days 1,8, 15 for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological complete response in the breast
Timepoint [1] 0 0
24 weeks (time window + 4 weeks)
Secondary outcome [1] 0 0
Pathologic Response rate in breast and axillary lymph nodes
Timepoint [1] 0 0
24 weeks (time window + 4 weeks)
Secondary outcome [2] 0 0
Rate of pathologic complete response and near complete response in the breast combined
Timepoint [2] 0 0
24 weeks (time window + 4 weeks)
Secondary outcome [3] 0 0
Breast conservation rate
Timepoint [3] 0 0
24 weeks (time window + 4 weeks)
Secondary outcome [4] 0 0
Progression Free Survival
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Safety and tolerability
Timepoint [5] 0 0
During treatment (24 weeks)

Eligibility
Key inclusion criteria
- The patient must have consented to participate and must have signed and dated an
appropriate approved consent form.

- Female 18 Years and older

- The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1

- The diagnosis of invasive adenocarcinoma of the breast must have been made by core
needle biopsy or limited incisional biopsy.

- Patients must have tumor diameter >2 cm measurable at least clinically; by physical
exam, unless the patient has inflammatory breast cancer, in which case measurable
disease by physical exam is not required or ultrasonographic staging (T2, T3 or T4 a,
b, c tumours with any clinical node status N0-N2).

- Left ventricular ejection fraction (LVEF) assessment by 2-D echocardiogram or Multi
Gated Acquisition Scan (MUGA scan) performed within 3 months prior to study entry must
be greater or equal to 50%.

- Adequate haematological, renal and hepatic function (neutrophils >=2 × 109/L,
platelets =100 × 109/L, hemoglobin >=100g/L, total bilirubin = 1.5 upper limit of
normal (ULN), aspartate aminotransferase and alanine aminotransferase =1.5 × ULN,
alkaline phosphatases =2.5 ULN, creatinine = 1.5 ULN).

- Negative pregnancy test
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe cardiovascular, hepatic, neurologic or renal comorbid conditions

- Primary surgical treatment of the tumor or excisional biopsy or lumpectomy performed
prior to study entry.

- Surgical axillary staging procedure prior to study entry.

- Definitive clinical or radiologic evidence of metastatic disease.

- History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral
ductal carcinoma in situ (DCIS) treated with radiotherapy (RT).

- Non-breast malignancies unless the patient is considered to be disease-free for 5 or
more years prior to study entry and is deemed by her physician to be at low risk for
recurrence. Patients with the following cancers are eligible if diagnosed and treated
within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal
cell and squamous cell carcinoma of the skin.

- Previous therapy with anthracyclines or taxanes for any malignancy.

- Treatment including RT, chemotherapy, and/or targeted therapy, administered for the
currently diagnosed breast cancer prior to study entry.

- Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other
Selective estrogen receptor modulator (SERM).

- Any sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement
therapy

- History of hepatitis B or C.

- Sensory/motor neuropathy greater or equal to grade 2, as defined by the current
version of the NCI's CTCAE.

- Pregnancy or continuing lactation at the time of study entry.

- Use of any investigational agent within 4 weeks prior to enrollment in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
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
1/06/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Bankstown Lidcome Hospital - Bankstown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Barwon Health - Geelong
Recruitment hospital [4] 0 0
St John of God Healthcare, Geelong - Geelong
Recruitment hospital [5] 0 0
South West Healthcare - Warrnambool
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3280 - Warrnambool

Funding & Sponsors
Primary sponsor type
Other
Name
Barwon Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this project is to evaluate tailored primary systemic therapy with sequential nab
paclitaxel and epirubicin and cyclophosphamide in early breast cancer. This study will be an
open label phase II clinical trial. The hypothesis is that tailored neoadjuvant chemotherapy
with sequential nab paclitaxel and epirubicin and cyclophosphamide is feasible and achieves
high response rates. It is proposed that 60 patients will be enrolled in this study including
40 patients which are likely to have chemotherapy sensitive tumors and 20 patients who have
ER positive tumors and are more likely to respond to hormonal treatment as an exploratory
cohort. The target population is women with early breast cancer who are eligible for primary
systemic therapy. The overall response rate in the breast will be measured. Secondary
endpoints will include response rates in axillary lymph nodes, safety and tolerability and
the rate of breast conservation. Participants will have a blood test to determine a specific
genotype status that may help in predicting sensitivity to chemotherapy. This genotype test
result is exploratory and will not influence selection of therapy for participants. Patients
will also be given the option of having he their tumour tissues used in laboratory studies
involving isolating cancer initiating cells from the tumor to subsequently generate breast
cancer models in the laboratory and using aptamers (chemical antibodies) to target tumours.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01830244
Trial related presentations / publications
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Public notes

Contacts
Principal investigator
Name 0 0
Mustafa Khasraw, MD
Address 0 0
Barwon Health
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01830244