A Phase II Study of Tetrathiomolybdate (TM) in Patients With Breast Cancer at Moderate to High Risk of Recurrence
1. Patients must have histologically confirmed breast malignancy that is:
- High risk stage II breast cancer (≥4 positive lymph nodes),
- Stage III breast cancer, including inflammatory breast cancer
- Stage IV breast cancer in a complete remission (bone only not allowed unless the
bone scan is normal).
2. The patient must have had what is considered standard adjuvant systemic therapy that
may include chemotherapy, hormonal therapy and radiation therapy. They may have
undergone high dose chemotherapy with stem cell support as part of their therapy in
the adjuvant or metastatic setting. The patient is allowed to continue to take
adjuvant hormonal therapy (for high risk adjuvant patients) and may be allowed to be
on hormonal consolidation post transplant if they are without evidence of disease
after a transplant for metastatic breast cancer. The patient cannot be actively
receiving chemotherapy or any biologic agent to treat their breast cancer.
3. Six weeks must elapse from last chemotherapy or radiation therapy.
4. The patient must have had definitive surgical therapy for their breast cancer. This
includes lumpectomy and axillary dissection or mastectomy.
5. No clinical or radiologic evidence of disease after surgery and/or systemic treatment
(by CT scan of chest, abdomen and pelvis and bone scan or PET scan prior to
6. Because no dosing or adverse event data are currently available on the use of TM in
patients < 18 years of age, children are excluded from this study.
7. ECOG performance status < 1
8. Life expectancy of greater than 3 months.
9. Patients must have normal organ and marrow function as defined below:
- hemoglobin >10mg/dL
- absolute neutrophil count >1,500/mL
- platelets >100,000/mL
- total bilirubin < 1.5 x normal institutional limits
- AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal
10. Erythropoietin alpha is allowed, as indicated.
11. Bisphosphonates may be administered if they were started prior to starting this
12. Patients must be on stable medical therapy for at least 2 weeks if they are being
treated medically for their peripheral neuropathy.
13. Concurrent herceptin is not allowed.
14. The effects of TM on the developing human fetus are unknown. For this reason, women
of child-bearing potential and men must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
15. Ability to understand and the willingness to sign a written informed consent
1. Patients who have had chemotherapy or radiotherapy within 6 weeks prior to entering
2. Objective evidence of breast cancer.
3. Carcinomatous meningitis or history of neoplastic parenchymal brain disease.
4. Serum creatinine >1.5 x normal.
5. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to TM.
6. Pregnant women are excluded from this study because TM has the potential to have
teratogenic or abortifacient effects. Because there is an unknown but potential risk
for adverse events in nursing infants secondary to treatment of the mother with TM,
breastfeeding should be discontinued if the mother is treated with TM.
7. Because patients with immune deficiency are at increased risk of lethal infections
when treated with marrow-suppressive therapy, HIV-positive patients receiving
combination anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with TM.