IST Neoadjuvant Abraxane in Newly Diagnosed Breast Cancer

NCT01830244 | Unknown Phase 2

• 1 other identifier: ALCC12.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer

Keywords

chemotherapy; nab paclitaxel; neoadjuvant therapy; breast cancer; pathologic complete response

Outcome Measures

Primary Outcomes (1)

• Pathological complete response in the breast

  Pathological complete response defined as breast only, ypT0/ ypTis regardless of nodal status

  24 weeks (time window + 4 weeks)

Secondary Outcomes (5)

• Pathologic Response rate in breast and axillary lymph nodes

  24 weeks (time window + 4 weeks)

• Rate of pathologic complete response and near complete response in the breast combined

  24 weeks (time window + 4 weeks)

• Breast conservation rate

  24 weeks (time window + 4 weeks)

• Progression Free Survival

  5 years

• Safety and tolerability

  During treatment (24 weeks)

Other Outcomes (1)

• NQ01*2 genotype (P187S) status

  Baseline

Study Arms (1)

Nab-Paclitaxel 125mg/m2

EXPERIMENTAL

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

Drug: Nab-Paclitaxel

Interventions

Nab-Paclitaxel DRUG

Nab-Paclitaxel- 125 mg/m2 days 1,8, 15 for 12 weeks

Also known as: Abraxane

Nab-Paclitaxel 125mg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barwon Health: lead

Study Sites (5)

Bankstown Lidcome Hospital

Bankstown, New South Wales, 2200, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

St John of God Healthcare, Geelong

Geelong, Victoria, 3220, Australia

Location

South West Healthcare

Warrnambool, Victoria, 3280, Australia

Location

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MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Mustafa Khasraw, MD

  Barwon Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: June 1, 2020
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

AU (5)