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A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer

In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been
in use for a long time. Gemcitabine is a treatment that is an effective therapy currently
available to patients with this type and stage of breast cancer. Frequently, in cancer
therapy, combinations of drugs prove more effective as treatment than the same drugs used
alone. The combination of gemcitabine and oxaliplatin has not been tested in patients with
triple negative breast cancer. It is hoped that the addition of oxaliplatin may cause your
tumor to stop growing or possible your tumor may shrink. This assessment will be basd on
measuring changes in the size of your tumor.

Inclusion Criteria:

- Histologically or cytologically confirmed ER-, PR-, Her2neu- (Triple Negative)
metastatic breast cancer

- Patients must have measurable disease according to the RECIST criteria. Patients
with bone metastases may be included if they have a decrease in performance status or
narcotic analgesic requirement.

- Patients must have either received a taxane in the adjuvant setting or received a
taxane as first-line treatment for metastatic breast cancer

- Age > 18 years

- ECOG Performance Score of 0, 1, or 2 (Appendix A)

- Adequate bone marrow as evidenced by:

- Absolute neutrophil count > 1,500/L

- Platelet count > 100,000/microL

- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL

- Adequate hepatic function as evidenced by:

- Serum total bilirubin < 1.5 mg/dL

- Alkaline phosphatase < 3X the ULN for the reference lab < 5X the ULN (Upper
limit for normal) for patients with known hepatic metastases

- SGOT/SGPT < 3X the ULN(Upper limit for normal) for the reference lab (< 5X the
ULN for patients with known hepatic metastases

- Patients must be recovered from both acute and late effects of any prior surgery,
radiotherapy or other antineoplastic therapy

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.

- Patients of childbearing potential agree to use an effective form of contraception
during the study and for 90 days following the last dose of study medication (an
effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

- Patients with an active infection or with a fever > 101.30 F within 3 days of the
first scheduled day of protocol treatment

- Patients with active CNS metastases. Patients with stable CNS disease, who have
undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
and who have been on a stable dose of corticosteroids for 3 weeks are eligible for
the trial

- History of prior malignancy within the past 5 years except for curatively treated
basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized
prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations at
least 3 months apart, with the most recent evaluation within 4 weeks of entry

- Patients with known hypersensitivity to any of the components of oxaliplatin or

- Patients who have received gemcitabine or platin-based chemotherapy in the past.

- Patients who have received chemotherapy within 28 days of the first scheduled day of
protocol treatment.

- Patients who received radiotherapy to more than 25% of their bone marrow; or patients
who received any radiotherapy within 4 weeks of entry

- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within 28 days of the first scheduled day of protocol
treatment (investigational therapy is defined as treatment for which there is
currently no regulatory authority approved indication)

- Peripheral neuropathy Grade 2

- Patients who are pregnant or lactating

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.

- History of allogeneic transplant

- Known HIV or Hepatitis B or C (active, previously treated or both)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.

Outcome Description:

A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Amelia Zelnak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

October 2009

Related Keywords:

  • Breast Cancer
  • Metastatic breast cancer
  • Breast Neoplasms



Emory University Winship Cancer InstituteAtlanta, Georgia  30322