Pathologic Complete Response (CR) Rate
| Group | Value |
|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml) | not posted |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) | not posted |
| Group 3 (E2 > 15 pg/ml) | not posted |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Due to funding source and lack of accrual
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
NCT01368263Sept 2011 to May 2013
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase II trial studies the impact of a presurgical endocrine therapy, consisting of goserelin with letrozole or anastrozole on the treatment of premenopausal patients with stage II-III estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Endocrine therapy reduces the amount of estrogen in the body. E+ breast cancer require estrogen, so lower levels of estrogen may slow or stop cell growth. Giving goserelin together with letrozole or anastrozole before surgery may enhance the effectiveness of, or eliminate the need for, chemotherapy
Experimental
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
Experimental
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Experimental
Group 3 (E2 > 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
Outcomes the sponsor listed as primary.
Pathologic Complete Response (CR) Rate
Time frame · 1 month
* In patients with Ki67 \>10% and \<= 15 pg/ml at 4 weeks. * The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy
Time frame · 6 months post neoadjuvant endocrine therapy and surgery
Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.
Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67
Time frame · Baseline and 4 weeks post-treatment
Preoperative Endocrine Prognostic Index Score (PEPI Score)
Time frame · At time of definitive surgery
To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less
Time frame · 16 weeks
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml) | not posted |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) | not posted |
| Group 3 (E2 > 15 pg/ml) | not posted |
| Group | Value |
|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml) | not posted |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) | not posted |
| Group 3 (E2 > 15 pg/ml) | not posted |
| Group | Value |
|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml) | not posted |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) | not posted |
| Group 3 (E2 > 15 pg/ml) | not posted |
| Group | Value (participants) |
|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml) | 1 |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) | not posted |
| Group 3 (E2 > 15 pg/ml) | not posted |
| Group | Value (percentage of participants) |
|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml) | 0 |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml) | not posted |
| Group 3 (E2 > 15 pg/ml) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group 1 (Ki67 <10%, E2 <= 15 pg/ml)Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion. | – | 0 / 6 | 6 / 6 |
| Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion. | – | 0 / 1 | 1 / 1 |
| Group 3 (E2 > 15 pg/ml)Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion. | – | 0 / 1 | 1 / 1 |
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