Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Carboplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.

Albumin-bound paclitaxel

Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.

Herceptin®

Andrew Seidman, MD

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer

Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.

Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.

Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.

A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above

Celgene

Albumin-bound Paclitaxel, Carboplatin + Herceptin

Age, Categorical

Age, Continuous

Sex: Female, Male

Black, of African Heritage

White, Non-Hispanic and Non-Latino

White, Hispanic or Latino

Race/Ethnicity, Customized

United States

Region of Enrollment

Pre-Menopausal

Post-Menopausal

Menopausal Status

0 (Fully Active)

1 (Restrictive but Ambulatory)

2 (Ambulatory, but Unable to Work)

A scale used to assess the progress of disease, how the disease affects the daily living abilities of the patient, and to determine appropriate treatment and prognosis.

0=Fully active, able to perform all pre-disease activity. 1=Restricted in physically strenuous activity, ambulatory, able to perform light work. 2=Ambulatory, capable of all selfcare, unable to carry out any work activities. Up and about \>50% of waking hours. 3=Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4=Completely disabled. Cannot perform any selfcare. Confined to bed or chair. 5=Dead.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Grade 0

Grade 1

The physician assessed sensory neuropathy using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) of "Neurology -- Neuropathy - Sensory". The scale is 0=normal and 1=asymptomatic; loss of deep tendon reflexes or paresthesia (including tingling) but not interfering with function. Data available for 31 participants.

Physician assessment of peripheral neuropathy

Carcinoma/Adenocarcinoma

Other

Histology of Primary Diagnosis

Time from first documented metastatic disease to study entry

Brain/Central Nervous System

Skin/Soft Tissue/Breast

Lymph Nodes

Lung

Liver

Peritoneal

Bone

Participants can be in multiple sites of metastasis/relapse categories.

Specific site(s) of metastasis/relapse

Visceral

Non Visceral

Dominant site of metastasis/relapse

0 or 1 lesion

2 to 3 lesions

> 3 lesions

Number of Lesions (Target + Non-Target)

Non visceral

Dominant Lesion Site (Target + Non-Target)

Associate Director, Clinical Trials Disclosure

The treated population consisted of all randomized participants who received at least one dose of study drug.

Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response

Percentage of Participants With a Total Response

Time to Disease Progression

Treated Population - Patients with a Confirmed Complete or Partial Overall Response

Duration of Response

Overall Patient Survival

Number with any treatment emergent AE

Number with any treatment-related AE

Number with any Grade 3/4 TEAE

Number with any serious AE

Number of Participants With Adverse Events (AEs)

Overall Study

Pharmaceutical Solutions

Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.

PF-05280014

A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m\^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m\^2 and then 60 mg/m\^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator.

Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion weekly until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the Herceptin® regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.

Pfizer CT.gov Call Center

The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280014 in combination with paclitaxel versus trastuzumab sourced from the European Union (trastuzumab-EU) with paclitaxel in female patients with HER2-positive, metastatic breast cancer in the first-line treatment setting. The hypothesis to be tested in this study is that the efficacy (ORR) of PF-05280014 is similar to trastuzumab-EU.

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)

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

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.

One-year PFS rate was analyzed based on the time from date of randomization to first documentation of progressive disease (PD), or death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. PD was defined for target disease as at least a 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy) with a minimum absolute increase of 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method.

DOR:time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review. As per RECIST v1.1, CR:complete disappearance of all target lesions with exception of nodal disease; all target nodes reduced in short axis \<10 mm. PR: \>=30% decrease from baseline of SOD of target lesions; short diameter used in sum for target nodes,longest diameter used in sum for other target lesions. PD for target disease:at least 20% increase in SOD of target lesions above smallest sum observed (over baseline if no decrease in sum observed) with minimum absolute increase of 5 mm. For non-target disease:unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. The 95% CI for median time to event was based on the Brookmeyer and Crowley method.

Overall survival was analyzed based on the time from date of randomization to the date of death due to any cause. Participants last known to be alive were censored on the date of last contact. The 95% CI for the median time to event was based on the Brookmeyer and Crowley Method.

Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific enzyme-linked immunosorbent assay (ELISA).

Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.

Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific ELISA.

Two sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) immunoassays, 1 for detecting antibodies against PF-05280014 and the other for detecting antibodies against trastuzumab, were used to analyze ADA samples. Serum samples were first screened for ADA. Any samples that were positive in the screening assay were further analyzed to confirm the positive result and determine the antibody titers. All samples were taken prior to dosing. The number of participants with a positive sample (titer \>=1.0) is provided.

Human serum samples testing positive for the presence of ADA (anti-PF-05280014 or anti-trastuzumab-EU) were analyzed for the presence or absence of NAb (neutralizing anti-PF-05280014 or neutralizing anti-trastuzumab-EU antibodies) following a tiered approach using screening and titer determination. The number of participants at baseline (prior to treatment) with a positive NAb sample (titer \>=1.48) is provided.

Pfizer

All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.

Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.

Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.

Trastuzumab-EU

Total

18 to 64

65 to 84

≥85

Age, Customized

The baseline analysis population was based on the safety population, which was defined as all participants who were randomized and treated with study drug.

Pfizer ClinicalTrials.gov Call Center

Risk Ratio and associated 95% confidence interval (CI) are unstratified and based on the Miettinen and Nurminen method.

The ITT population was defined as all participants who were randomized to study drug.

Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population

One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population

The ITT population was defined as all participants who were randomized to study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Duration of Response (DOR) Per Central Radiology Assessments: ITT Population

Overall Survival: ITT Population

Cycle 1 Day 1

Cycle 5 Day 1

PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "number analyzed (n)" signifies participants evaluable at specified time points only.

Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population

PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "n" signifies participants evaluable at specified time points only.

Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population

Cycle 1 Day 8

Cycle 3 Day 1

Cycle 4 Day 1

Cycle 5 Day 8

Cycle 7 Day 1

Cycle 8 Day 1

Cycle 11 Day 1

Cycle 14 Day 1

Cycle 17 Day 1

PK population.Here "n" signifies participants evaluable at specified time points only.The Cycle 17 Day 1 (C17D1) samples summarized previously at PCD (Week 33) fell outside of cut-off used for final analysis (Week 53), to limit data for up to 1-year post randomization, which was more conservative from previous Week 33 analysis. While comparing data between Week 33 and Week 53, there was a significant drop off in number of samples summarized at C17D1 and was down to zero for this outcome measure.

Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population

Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population

Cycle 1 Day 1 (prior to treatment)

Safety population was used for analysis, included all participants who received at least 1 dose of study drug. Here "n" signifies participants evaluable at specified time points only.

Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population

Safety population was used for analysis, included all participants who received at least 1 dose of study drug.

Number of Participants With Positive Neutralizing Antibodies (Nab) Prior to Treatment: Safety Population

Docetaxel

Participants received intravenous infusion of QL1701 with docetaxel. The initial load dose of QL1701 was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks.

Participants received intravenous infusion of Herceptin® with docetaxel. The initial load dose of Herceptin® was 8mg/kg, followed by 6mg/kg every three weeks; The recommended dose of docetaxel is 75mg/m2, given once every 3 weeks for a treatment cycle of 3 weeks.

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

QL1701

The recommended dose is 75mg/m2 and the infusion time is approximately 70min (±20min) (or adjusted according to clinical experience at each study center). The drug was administered once every 3 weeks for a treatment cycle of 3 weeks, with the exception of the second day of the first cycle, followed by the first day of each cycle for at least 8 cycles

This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.

This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of QL1701 and Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, recurrent or previously untreated metastatic breast cancer. Eligible patients will be assessed centrally for HER2 status and the presence of at least one measurable target lesion before randomization. Patients will undergo a tumor assessment for evaluation of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) every 6 weeks up to 24 weeks (regardless of the number of cycles actually given);

A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer

calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.

alculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1.

The probability of being alive without documented progression up to 12 months after randomization

The time from first documentation of CR or PR to the first documentation of progression

The proportion of patients who achieve CR, PR, or stable disease (SD) of at least 12 weeks

the probability of being alive 12 months after randomization

Qilu Pharmaceutical Co., Ltd.

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Epirubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

TX05 (trastuzumab)

175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)

75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Bonnie Mills, PhD

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer

Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.

Tanvex BioPharma USA, Inc.

Because study drug (TX05/trastuzumab) was not introduced until Cycle 5 of treatment, the analyses of AEs was focused on Cycles 5 through 8 of treatment. The following results include events that occurred on or after initiation of TX05 or Herceptin treatment.

• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

TX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

Paclitaxel: 175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)

Epirubicin: 75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

Cyclophosphamide: 600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

TX05 (Trastuzumab)

• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

Herceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

Paclitaxel: 175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)

Epirubicin: 75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

Cyclophosphamide: 600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Hormone Receptor Status

Grade 0: Fully active, able to carry on all pre-disease activities without restriction

Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.

Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.

Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

Grade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

Grade 5: Dead

ECOG

* Enrolled subjects should have Stage II/IIIa breast cancer.
* Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor size, lymph node involvement, metastasis to distant sites) staging system.
* A low grade number (grade 1) usually means the cancer is slower-growing and less likely to spread. A high grade number (grade 3) means a faster-growing cancer that's more likely to spread. An intermediate grade number (grade 2) means the cancer is growing faster than a grade 1 cancer but slower than a grade 3 cancer.

Tumor Stage

Safety population/The modified intent-to-treat (mITT) population includes all subjects who are randomized into the study and receive at least 1 dose of TX05 or Herceptin.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer	NCT00093145	Breast Cancer	Albumin-bound p... Carboplatin Herceptin®	18 Years -	Celgene
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)	NCT01989676	Metastatic Brea...	PF-05280014 Paclitaxel Herceptin® Paclitaxel	18 Years -	Pfizer
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer	NCT05629949	Breast Cancer	QL1701 Herceptin® Docetaxel	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer	NCT03556358	Breast Cancer Breast Neoplasm... HER2-positive B... Stage II Breast... Stage IIIA Brea...	TX05 (trastuzum... Herceptin® Paclitaxel Epirubicin Cyclophosphamid...	18 Years -	Tanvex BioPharma USA, Inc.
Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer	NCT00031278	Carcinoma, Meta...	CPG 7909 Herceptin® CPG 7909 Herceptin® CPG 7909 Herceptin® CPG 7909 Herceptin®	18 Years -	Pfizer
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer	NCT03425656	Malignant Neopl...	Trastuzumab plu...	18 Years - 70 Years	AryoGen Pharmed Co.
Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer	NCT03084237	Breast Cancer	HLX02 Herceptin® docetaxel	18 Years -	Shanghai Henlius Biotech
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer	NCT05629949	Breast Cancer	QL1701 Herceptin® Docetaxel	18 Years - 75 Years	Qilu Pharmaceutical Co., Ltd.
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer	NCT03556358	Breast Cancer Breast Neoplasm... HER2-positive B... Stage II Breast... Stage IIIA Brea...	TX05 (trastuzum... Herceptin® Paclitaxel Epirubicin Cyclophosphamid...	18 Years -	Tanvex BioPharma USA, Inc.

Spots Global Cancer Trial Database for herceptin®

Every month we try and update this database with for herceptin® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for herceptin®

Every month we try and update this database with for herceptin® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for herceptin® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.