N/A
Completed N=182
DNA in Predicting Response After Systemic Therapy in Women With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00899548 ↗Enrolled (actual)
182
Serious AEs
1.7%
Results posted
Jul 2019
Primary outcomePrimary: Progression-free Survival in Patients With a High vs. Low Cumulative Methylation Index (CMI) Value — 2.1; 5.8 months — p=.0002
Summary
RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to systemic therapy.
PURPOSE: This laboratory study is looking at DNA in predicting response after systemic therapy in women with metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival in Patients With a High vs. Low Cumulative Methylation Index (CMI) Value |
2.1; 5.8 | .0002 sig |
| PRIMARY Changes in Methylated Gene Markers as Measured by Cumulative Methylation Index |
-1.20 | 0.001 sig |
| PRIMARY Effects of Common Exposures (i.e., Alcohol, Smoking, Medications, and Dietary Factors) on Patterns of Serum Methylation |
— | — |
| PRIMARY Creation of a Predictive Model of DNA Methylation Profiles |
— | — |
| SECONDARY Overall Survival in Patients With a High vs. Low CMI Value |
12.3; 21.7 | .001 sig |
| SECONDARY Correlation of CTCs With Serum Methylation |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Histologically and/or cytologically confirmed stage IV adenocarcinoma of the breast (patient)
- No diagnosis of an abnormal breast biopsy (including atypical ductal or lobular hyperplasia), or new diagnosis of breast cancer or breast cancer recurrence within the past five years (healthy participant)
- Evidence of disease progression AND initiating a new systemic treatment regimen with trastuzumab (Herceptin®), chemotherapy, endocrine therapy, or investigational agent(s) (patient)
- Treatment may be given as a single agent or in combination
- Measurable or evaluable disease (patient)
- Measurable disease is defined as ≥ 1 measurable lesion identified by RECIST criteria
- Patients with evaluable disease only must have ≥ 1 tumor marker (e.g., carcinoembryonic antigen, CA 27-29, or CA 15-3) above normal level
- Treated brain metastases (surgery or radiation therapy) allowed provided patient has evidence of disease stability or presence of other site(s) of measurable or evaluable disease (patient)
- No leptomeningeal disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- No known cancer within the past 5 years other than basal cell or squamous cell carcinoma of the skin and/or adequately treated cervical cancer (healthy participant)
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior therapy in the preoperative, adjuvant, and/or metastatic setting allowed
- Any number of prior regimens in any setting allowed
- No prior radiation therapy to the only site of disease unless there is evidence of post-radiation disease progression
- No selective estrogen receptor modulator or aromatase inhibitor for breast cancer prevention or therapy within the past 12 months (healthy participant)
- Prior or concurrent use of raloxifene for osteopenia or osteoporosis therapy allowed (healthy participant)
- Concurrent participation in another clinical trial, including one involving an investigational agent(s), allowed
Data sourced from ClinicalTrials.gov (NCT00899548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.