Pathological Complete Response Rate
| Group | Value (participants) |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | 0 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Study did not pass Stage 1 interim analysis.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
NCT01776008Jan 2013 to 5 May 2015
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer. MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK-2206, anastrozole, and goserelin acetate together may kill more tumor cells.
Experimental
Treatment (MK2206, anastrozole, goserelin acetate)
Patients receive Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; anastrozole PO daily on days 1-28; and goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Outcomes the sponsor listed as primary.
Pathological Complete Response Rate
Time frame · At time of surgery (up to 3 weeks after 4, 28-day cycles)
Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach.
Clinical Response Rate
Time frame · Baseline to end of Cycle 4 (28 day cycles)
The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on physical examination divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.
Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Time frame · Baseline to end of Cycle 4 (28 day cycles)
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the number of patients that reported a grade 3 or higher graded adverse event during neoadjuvent treatment. A complete list of all reported adverse events is in the Adverse Events section of the report.
Radiological Response Rate
Time frame · Baseline and completion of cycle 4 (28 day cycles)
The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on radiographic evaluation (mammogram or ultrasound) divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | 0 |
| Group | Value |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | not posted |
| Group | Value (Participants) |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | 6 |
| Group | Value |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | not posted |
| Group | Value |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | not posted |
| Group | Value |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | not posted |
| Group | Value |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | not posted |
| Group | Value |
|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treatment (MK2206, Anastrozole, Goserelin Acetate)Patients receive 150 mg Akt inhibitor MK-2206 PO on days 2, 9, 16, and 23; 1 mg anastrozole PO daily on days 1-28; and 3.6 mg goserelin acetate SC on day 1 (premenopausal patients only). Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. | 0 / 16 | 1 / 16 | 16 / 16 |
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