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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

NCTNCT00194792 (opens ClinicalTrials.gov in a new tab)Other id6277Other idNCI-2010-00549

Overview

Status
Terminated
Phase
Phase 2
Enrollment
28 participants (actual)
Sponsor
University of Washington · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2005
Primary completion
Jul 2011
Completion
Jul 2011
First posted
19 Sept 2005 (estimated)
Last update posted
11 Jul 2017
Conditions
Estrogen Receptor-positive Breast Cancer · HER2-negative Breast Cancer · Progesterone Receptor-positive Breast Cancer · Stage I Breast Cancer · Stage II Breast Cancer · Stage IIIA Breast Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 2

    Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

    NCT00194792

    Aug 2005 to Jul 2011

    Terminated

Registry summary

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

Interventions

  • exemestaneDrug
  • triptorelin pamoateDrug
  • capecitabineDrug
  • methotrexateDrug
  • vinorelbine tartrateDrug
  • paclitaxelDrug
  • therapeutic conventional surgeryProcedure
  • radiation therapyRadiation
  • laboratory biomarker analysisOther

Arms1

  • Experimental

    Treatment (hormone therapy and chemotherapy)

    See detailed description

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Number of Participants With Clinical Response

    Time frame · 1 month

    Registry description

    Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.

  2. Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response

    Time frame · From date of treatment start to surgery

    Registry description

    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.

  3. Disease-free Survival

    Time frame · Up to 5 years

    Registry description

    Kaplan-Meier estimate assessed at 5 years

  4. Overall Survival

    Time frame · Up to 5 years

    Registry description

    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.

  5. 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)

    Registry description

    Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities

  6. Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation

    Time frame · During adjuvant and neoadjuvant chemotherapy

    Registry description

    Count of patients with dose reduction, treatment interruption, or treatment discontinuation.

Secondary outcomes(1)
  1. Correlation of Molecular Markers With Response, Time to Progression, and Survival

    Time frame · Weekly during CHB and XMN and pacitaxel

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 1 month

Number of Participants With Clinical Response

GroupValue (Participants)
Treatment (Hormone Therapy and Chemotherapy)19
Primary outcomeCount of participants· From date of treatment start to surgery

Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response

GroupValue (Participants)
Treatment (Hormone Therapy and Chemotherapy)0
Primary outcomeNumber· Up to 5 years

Disease-free Survival

GroupValue (disease free survival probability)
Treatment (Hormone Therapy and Chemotherapy)0.76
Primary outcomeNumber· Up to 5 years

Overall Survival

GroupValue (survival probability)
Treatment (Hormone Therapy and Chemotherapy)0.88
Primary outcomeNumber· Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)

Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities

GroupValue (events)
Treatment (Hormone Therapy and Chemotherapy)80
Primary outcomeCount of participants· During adjuvant and neoadjuvant chemotherapy

Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation

GroupValue (Participants)
Treatment (Hormone Therapy and Chemotherapy)1
Secondary and other outcome results(1)
Secondary outcome· Weekly during CHB and XMN and pacitaxel

Correlation of Molecular Markers With Response, Time to Progression, and Survival

GroupValue
Treatment (Hormone Therapy and Chemotherapy)not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 2723 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have histologically confirmed, operable ER or PR +, HER2/neu negative, radiographically measurable breast cancer \> 1cm (Operable lesions are T1c - T3 and N0 - N2a; histologic confirmation should be by core needle biopsy only) * Be chemotherapy naive * Have an ECOG performance status of =\< 2 * Be assessed for menopausal status (For study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or age 60 or older with a prior hysterectomy without oophorectomy, or Age less than 60 with a prior hysterectomy without oophorectomy \[or in whom the status of the ovaries is unknown\], with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab) * All premenopausal patients must have a baseline FSH and LH * ANC \>= 1,500 * Platelet count \>= 100,000 * Serum creatinine =\< 1.5 x IULN * Estimated creatinine clearance \> 50 ml/min * Have staging studies and tumor assessment prior to registration * Bone density exam must be done within the first 3 months of complete hormonal blockade * Have a negative pregnancy test within seven days prior to registration if of childbearing potential * Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures Exclusion Criteria: * Primary tumor =\< 1 cm, not measurable; inflammatory disease * Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded (Women of childbearing potential who are not using a reliable and appropriate contraceptive method are excluded; patients must agree to continue contraception for 30 days from the last study drug administration) * Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil * Previous enrollment in an investigational drug study within the last 4 weeks * Evidence of distant metastatic disease * Prior chemotherapy or hormonal therapy for breast cancer * Prior malignancy other than adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, other stage I or II cancer from which the patient has been disease free for at least 5 years * History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake * Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication or myocardial infarction * Major surgery within four weeks of the start of study treatment without complete recovery * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome * Known, existing uncontrolled coagulopathy * Unwillingness to give informed consent * Unwillingness to participate or inability to comply with the protocol for the duration of the study

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