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Brand name(s): Abraxane™

• Approved for breast cancer

Full prescribing information ³ is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On January 7, 2005, the U.S. Food and Drug Administration approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane™, a trademark of American BioScience, Inc.) for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Nanoparticle paclitaxel is also called paclitaxel albumin-stabilized nanoparticle formulation. Prior therapy should have included an anthracycline unless clinically contraindicated.

The clinical database included two single arm studies enrolling a total of 106 patients and one multicenter randomized trial. The multicenter trial was conducted in 460 patients with metastatic breast cancer who were randomized to receive either nanoparticle paclitaxel 260 mg/m2 administered as a 30-minute infusion or paclitaxel 175 mg/m2 given over three hours.

Fifty-nine percent of patients had received one or more prior chemotherapy regimens, and 77 percent had received an anthracycline-containing regimen. The objective response rate verified by central review was 21.5 percent (95 percent CI: 16.2 percent to 26.7 percent) for nanoparticle paclitaxel compared to 11.1 percent (95 percent CI: 6.9 percent to 15.1 percent) for paclitaxel (p=0.003).

Clinically important adverse events (all grade) in the randomized trial comparing nanoparticle paclitaxel to paclitaxel included neutropenia (80 percent with nanoparticle paclitaxel and 82 percent with paclitaxel), anemia (33 percent vs. 25 percent), infections (24 percent vs. 20 percent), hypersensitivity reactions (4 percent vs. 12 percent), sensory neuropathy (71 percent vs. 56 percent), edema (10 percent vs. 8 percent), nausea (30 percent vs. 21 percent), vomiting (18 percent vs. 9 percent), diarrhea (26 percent vs. 15 percent), and mucositis (7 percent in both arms).

Severe adverse events (grade 3 or 4) included neutropenia (9 percent with nanoparticle paclitaxel and 22 percent with paclitaxel), myalgia/arthralgia (8 percent vs. 4 percent) and vomiting (4 percent vs. 1 percent). Ten percent (24 patients) treated with nanoparticle paclitaxel developed grade 3 peripheral neuropathy; 14 of these patients showed some improvement of neuropathy at a median of 22 days. Two percent of patients receiving paclitaxel developed grade 3 peripheral neuropathy.

The recommended dose of nanoparticle paclitaxel is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks. No premedication to prevent hypersensitivity reactions is required prior to nanoparticle paclitaxel administration.

Glossary Terms

Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

A type of antibiotic that comes from certain types of Streptomyces bacteria. Anthracyclines are used to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing them to die. Daunorubicin, doxorubicin, and epirubicin are anthracyclines.

Swelling caused by excess fluid in body tissues.

The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).

A complication of some cancer therapies in which the lining of the digestive system becomes inflamed. Often seen as sores in the mouth.

A nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Neuropathy may be caused by physical injury, infection, toxic substances, disease (such as cancer, diabetes, kidney failure, or malnutrition), or drugs, including anticancer drugs. Also called peripheral neuropathy.

A condition in which there is a lower-than-normal number of neutrophils (a type of white blood cell).

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.