Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Hematinics

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Mitogens

Darbepoetin alfa

6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy

Neulasta

If Hb drops below 110, 300mcg Aranesp will be administered.

Aranesp

This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.

ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer

An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer

Amgen

Global Development Leader

Anti-Infective Agents

Trastuzumab

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery

100 MG/M2 IV over 30 minutes once a week for 12 weeks

nab-paclitaxel

4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks

trastuzumab

60 MG/M2 every two weeks for a total of 4 cycles

600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)

cyclophosphamide

* All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.
* Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.

Growth Factor Support

* After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.
* All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.

Surgery

Qamar Khan, MD

The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.

Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.

A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.

The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.

Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression

Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)

Celgene Corporation

University of Kansas Medical Center

Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide, Growth Factor Support, Surgery

nab-paclitaxel: 100 MG/M2 IV over 30 minutes once a week for 12 weeks

trastuzumab: 4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks

Doxorubicin: 60 MG/M2 every two weeks for a total of 4 cycles

cyclophosphamide: 600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)

Growth Factor Support: - All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.

- Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician.

Surgery: -After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.

-All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer	NCT00261313	Breast Cancer	Neulasta Aranesp	18 Years -	Amgen
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer	NCT00261313	Breast Cancer	Neulasta Aranesp	18 Years -	Amgen
Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression	NCT00944047	Breast Cancer	nab-paclitaxel trastuzumab Doxorubicin cyclophosphamid... Growth Factor S... Surgery	18 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for growth factor support