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SCCA Breast Cancer Clinical Trials

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate (Sutent) in Combination With Weekly Paclitaxel (Taxol) Followed by Doxorubicin (Adriamycin) and Daily Oral Cyclophosphamide (Cytoxan) Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer
Status Conditions Phase Study ID
Closed Breast Cancer III UW11015
NCT01077154
Summary

The purpose of this randomized Phase III trial is to study the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.


Rationale: For women with early-stage breast cancer, bone is a frequent site of relapse, and most women with advanced breast cancer will eventually develop disease in the bone.

Denosumab, a fully human monoclonal antibody that specifically inhibits RANK ligand, may have the potential to interrupt the hypothetical "vicious cycle" of cancer-induced bone destruction and tumor cell expansion through the bone. It is not yet known if denosumab may prevent disease recurrence in the bone or in any other part of the body.


Investigator
Georgiana K. Ellis, MD
Eligibility Criteria (must meet the following to participate in this study)

Inclusion Criteria

  • Histologically confirmed stage II or III breast cancer
  • High risk of breast cancer, meeting one or more of the following criteria:
    • Biopsy evidence of breast cancer in regional lymph nodes (micrometastases only would not be considered node positive disease)
    • Tumor size > 5 cm (T3) or locally advanced disease (T4)
       
  • Documented ER, PR and HER2 assessment
  • Subjects must be receiving or be scheduled to receive standard of care systemic adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or HER2 targeted therapy
  • For subjects receiving adjuvant treatment
i. Subjects must have undergone complete resection of the primary tumor with clean margins OR
ii. Subjects must have undergone resection of the primary tumor and be scheduled for further treatment of the primary tumor with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
iii. Time between definitive surgery and randomization must be ≤ 12 weeks
iv. Subjects with node positive disease must have undergone treatment of axillary LN with curative intent OR
v. Subjects must be scheduled for further treatment or regional lymph nodes with curative intent. Definitive treatment must be planned to be completed within approximately 9 months of randomization
vi. Subjects must NOT have received prior neoadjuvant treatment
  • For subjects receiving neoadjuvant treatment only:
i. Time between start of neoadjuvant treatment and randomization must be ≤8 weeks
ii. Subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately 9 months of starting neoadjuvant treatment
 
  • Negative pregnancy test within 14 days of randomization
  • Serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
  • ECOG 0 or 1
Exclusions (conditions that would prevent participation in this study)
  1. Prior or current evidence of any metastatic involvement of any distant site
  2. History of breast cancer (other than DCIS or LCIS) prior to the current dx
  3. Osteoporosis requiring treatment at the time of randomization or treatment likely to become necessary within the subsequent six months
  4. Any prior or synchronous malignancy, except:
    a. Malignancy treated with curative intent and with no evidence of disease for ≥ 5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician
    b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  5. Active infection with Hepatitis B virus or Hepatitis C virus
  6. Known infection with HIV
  7. Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
  8. Active dental or jaw condition which requires oral surgery
  9. Planned invasive dental procedure for the course of the study
  10. Non-healed dental or oral surgery
  11. Use of oral bisphosphonates within the past 1 year
  12. Prior or current IV bisphosphonate administration
  13. Prior administration of denosumab
  14. Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
  15. Subject is pregnancy or breast feeding, or planning to become pregnant within 7 months after the end of treatment
  16. Subject is of child bearing potential and is not willing to use, in combination with he partner, 2 highly effective methods of contraception or abstinence during treatment and for 7 months after the end of treatment
Last Updated
February 11, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.