A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT01989676
• Date of registration: 28/10/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
• Scientific title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER
• Date of first enrolment: February 24, 2014
• Target sample size: 707
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01989676
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Chile, Czech Republic, Czechia, Greece, Hungary, India, Japan, Korea, Republic of, Latvia, Mexico, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed diagnosis of breast cancer.

- Presence of metastatic disease.

- Documentation of HER2 gene amplification or overexpression.

- Available tumor tissue for central review of HER2 status.

- At least 1 measurable lesion as defined by RECIST 1.1.

- Eastern Cooperative Oncology Group status of 0 to 2.

- Left ventricular ejection fraction within institutional range of normal, measured by
either two dimensional echocardiogram or multigated acquisition scan.

Exclusion Criteria:

- Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant)
treatment (except endocrine therapy) and within 1 year before randomization.

- Prior systemic therapy for metastatic disease (except endocrine therapy).

- Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m^2, or
the equivalent dose for other anthracyclines or derivatives (eg, 72 mg/m^2 of
mitoxantrone). If the patient has received more than one anthracycline, then the
cumulative dose must not exceed the equivalent of 400 mg/m^2 of doxorubicin.

- Inflammatory breast cancer.

- Active uncontrolled or symptomatic central nervous system metastases.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: Paclitaxel

Biological: PF-05280014

Biological: Herceptin®

Primary Outcome(s)

Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population [Time Frame: From the date of randomization until the cutoff date of 24 August 2016 when all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit.]

Secondary Outcome(s)

Neutralizing Antibodies (Nab) Incidence at Cycle 1 Day 1 Prior to Treatment: Safety Population [Time Frame: Available data from Baseline to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.]

One-year Survival Rate: ITT Population [Time Frame: From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.]

Serum Peak (1 Hour Post End of Infusion) Concentration of Trastuzumab-EU at Selected Cycles: PK Population [Time Frame: Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016]

Duration of Response (DOR) Per Central Radiology Assessments: ITT Population [Time Frame: From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.]

Serum Peak (1 Hour Post End of Infusion) Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population [Time Frame: Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016]

One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population [Time Frame: From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.]

Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population [Time Frame: Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.]

Anti-Drug Antibodies (ADA) Incidence: Safety Population [Time Frame: Available data from Baseline through Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.]

Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population [Time Frame: Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.]

Secondary ID(s)

2013-001352-34

REFLECTIONS B327-02

B3271002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/01/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01989676