Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)

NCT01416558 | Terminated Phase 2 DMC

• 2 other identifiers: GBG 652011-000075-13
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment for patients with an early relapse (\<12 months) after a taxane containing (neo-)adjuvant therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only limited cross-resistant to solvent-based taxanes and might therefore be indicated in this setting.

Conditions

Metastatic Breast Cancer

Keywords

German Breast Group; GBG Forschungs GmbH; GBG; GBG 65; Tiffany; Breast Cancer; Metastatic Breast Cancer; Nab-Paclitaxel; Abraxane; Taxane Failure

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  3 years

Secondary Outcomes (7)

• Toxicity of the therapy

  3 years

• Clinical benefit rate (CBR) in patients with measurable disease

  3 years

• Duration of response

  3 years

• Progression-free survival (PFS)

  3 years

• Overall survival (OS)

  3 years

Interventions

Nab-Paclitaxel DRUG

Nab-Paclitaxel 125 mg/m2 i.v. over 30 min. weekly in 5 out of 6 weeks Given until progression, unacceptable toxicity, patient's request or withdrawal from Study

Also known as: Abraxane, EU/1/07/428/001

Eligibility Criteria

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

You may qualify if:

• Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
• Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.
• Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer.
• Relapse within ≤ 12 months after completing (last day of last cycle) (neo-) adjuvant chemotherapy.
• Documented relapse of either a measurable or a non-measurable lesion according to the modified RECIST criteria.
• Previous neoadjuvant or adjuvant treatment with a solvent based taxane (paclitaxel or docetaxel) irrespective of dose and duration.
• Prior endocrine treatment for metastatic / advanced disease is allowed.
• Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.
• Age ≥ 18 years.
• ECOG Performance Status ≤ 2 (irrespective of restrictions due to breast cancer).
• Laboratory requirements:Absolute neutrophil count (ANC) \>= 1.5 x 109/L., Platelets \>= 100 x 109/L., Hemoglobin \>= 9 g/dL (\>= 5.6 mmol/L)., Prothrombin time (PT) or international normalized ratio (INR) \<= 1.2x ULN (upper normal limit), Partial thromboplastin time (PTT) \<= 1.2x ULN, Total bilirubin \< 1.5x ULN, ASAT (SGOT) and ALAT (SGPT) \<= 2.5x ULN (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x ULN are not permitted), Creatinine clearance \>= 50 mL/min), Urine Protein to Creatinine Ratio (UPC) \< 1 (if UPC \>= 1, then 24-hour urine protein must be \< 1 g).
• Normal cardiac function confirmed by ECG.
• A female either of: 1) Non-childbearing potential, i.e. physiologically incapable of becoming pregnant because of history of hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation or postmenopausal status.
• \) Childbearing potential with a negative pregnancy test (urine or serum)within 2 weeks prior to registration, preferably as close to the first dose as possible, and agrees to use adequate contraception.
• Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:

You may not qualify if:

• Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances.
• (Neo-)adjuvant therapy not containing a solvent based taxane.
• (Neo-)adjuvant therapy with nab-paclitaxel.
• Concurrent hormonal therapy for cancer.
• Life expectancy less than 3 months.
• Pre-existing peripheral neuropathy of \> grade 2 (per CTCAE).
• Pre-existing grade 3 or 4 diarrhea.
• Presence of uncontrolled infection.
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with the subject's safety, provision of informed consent, or compliance to study procedures.
• Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds during study treatment.

Sponsors & Collaborators

• GBG Forschungs GmbH: lead

Study Sites (1)

GBG Forschungs GmbH

Neu-Isenburg, 63263, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

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

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 15, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 22, 2013

Record last verified: 2013-05

Locations

DE (1)