Number of Participants With Clinical Response
| Group | Value (Participants) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 19 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer
NCT00194792Aug 2005 to Jul 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery
Experimental
Treatment (hormone therapy and chemotherapy)
See detailed description
Outcomes the sponsor listed as primary.
Number of Participants With Clinical Response
Time frame · 1 month
Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.
Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
Time frame · From date of treatment start to surgery
Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.
Disease-free Survival
Time frame · Up to 5 years
Kaplan-Meier estimate assessed at 5 years
Overall Survival
Time frame · Up to 5 years
From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
Time frame · Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)
Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities
Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Time frame · During adjuvant and neoadjuvant chemotherapy
Count of patients with dose reduction, treatment interruption, or treatment discontinuation.
Correlation of Molecular Markers With Response, Time to Progression, and Survival
Time frame · Weekly during CHB and XMN and pacitaxel
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 19 |
| Group | Value (Participants) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 0 |
| Group | Value (disease free survival probability) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 0.76 |
| Group | Value (survival probability) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 0.88 |
| Group | Value (events) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 80 |
| Group | Value (Participants) |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | 1 |
| Group | Value |
|---|---|
| Treatment (Hormone Therapy and Chemotherapy) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treatment (Hormone Therapy and Chemotherapy)See detailed description exemestane: Given PO triptorelin pamoate: Given IM capecitabine: Given PO methotrexate: Given IV vinorelbine tartrate: Given IV paclitaxel: Given IV therapeutic conventional surgery: Undergo lumpectomy or mastectomy radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies | – | 0 / 27 | 23 / 27 |
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