Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Carboplatin

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC

Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks

Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year

TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.

Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1

Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1

Pegfilgrastim 6mg SC, day 2 Cycled as per arm

Pegfilgrastim

Trastuzumab 6mg/kg every 21 days to complete 1 year

Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.

80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15

Aarti Bhardwaj, MD

Primary Objective:

• Determination of pathologic complete response (pCR) rates

Secondary Objective:

* Determination of cardiac toxicity as measured by: composite of LVEF, longitudinal strain and troponin.
* Breast conservation rates
* Overall survival

Study Design

* Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will be enrolled.
* Patients will be stratified by ER/PR status.
* They will be randomized to ddACTHP vs TCHP.

  * Initially, 17 patients will be randomly assigned to each treatment arm.
  * If 3 or fewer patients have a pCR, then that arm will be terminated and no further patients will be entered on that treatment arm.
  * If 4 or more patients obtain a pCR, 20 additional patients (total of 37 patients) will be randomized to that treatment arm.
  * If 11 or more patients out of 37 have a pCR, the treatment will be of interest for further study.

Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

A Phase II Randomized Trial Evaluating Neoadjuvant Dose-Dense Doxorubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab/Pertuzumab (AC THP) and Docetaxel/Carboplatin/Trastuzumab/Pertuzumab (TCHP) For Early Her2Neu Positive Breast Cancer

Pathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy.

Determination of cardiac toxicity as measured by LVEF, longitudinal strain and troponin.

Left ventricular ejection fraction (LVEF) measurement of amount of blood being pumped out of the left ventricle of the heart with each contraction.

Peak systolic longitudinal strain is calculated by averaging the values of peak systolic strain in the basal, mid and apical segments of the LV in 4-, 3- and 2-chamber views on echocardiograms. A value of \<-18% or a \>15% decline in strain from patient's baseline value will be used as a cut-off value.

A value of troponin I \> 0.08 ng/ml will be considered elevated.

The frequency of adverse events categorized using CTCAE v4.03

Number of participants with breast-conserving surgery for patients for whom mastectomy was planned before treatment. It would be based on surgical opinion at time of surgery if the tumor was appropriately "downstaged" to perform breast conserving surgery on patients previously recommended to have a mastectomy.

Overall Survival - Number of participants alive at the end of the study.

Icahn School of Medicine at Mount Sinai

Assistant Professor

Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC

Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks

Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year

Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1

Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year

Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.

Doxorubicin: Doxorubicin 60 mg/m2 IV day 1

Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1

Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15

ddACTHP

TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.

Docetaxel: Docetaxel 75mg/m2 IV, day 1

Carboplatin: Carboplatin AUC 6 IV, day 1

Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1

Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1

Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm

Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year

Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour.

Spots Global Cancer Trial Database for Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial