HER2-negative Breast CancerPhase 3NCT00003440
Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic
A Phase 3 study testing paclitaxel, trastuzumab and quality-of-life assessment in people with HER2-negative Breast Cancer and HER2-positive Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-negative Breast Cancer, HER2-positive Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- paclitaxel, trastuzumab and quality-of-life assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the female breast which is inoperable, recurrent or metastatic
- HER-2/neu status must be known at the time of protocol registration; HER-2/neu assessment will be based on FISH analysis of either the primary tumor or a metastatic site; a scoring of 0 or 1+ by immunohistochemistry (IHC) is considered negative; 2+ is considered negative unless confirmed by FISH positivity, in which case it should be considered positive; 3+ by IHC is considered positive; for centers using FISH only, a positive FISH assay by itself is sufficient to determine HER-2 positivity
- Patients with the following prior therapy are eligible:
- Patients with 0-1 prior chemotherapy regimens for metastatic or locally advanced breast cancer, with the following exception: no prior taxane for metastatic/locally advanced breast cancer
- Patients with 0-1 prior chemotherapy regimens in the adjuvant setting; if adjuvant regimen included a taxane, patient must have been disease free for at least 12 months from completion of adjuvant therapy until relapse
- Patients must be > 2 weeks from prior surgery, other than simple biopsy or placement of venous access device; patients must be > 4 weeks from prior chemotherapy; patients must be >6 weeks from nitrosoureas, melphalan, or mitomycin
Show all 25Show fewer
- Patients must be > 4 weeks from prior hormonal therapy unless tumor measurements document clear progression while on treatment; if progression is documented and toxicity from hormonal regimen has resolved, patients may be placed on study > 1 week from prior hormonal therapy
- Prior Herceptin therapy is not allowed
- Patients with central nervous system metastases are eligible only if the patient has completed cranial irradiation at least 6 months prior, is currently asymptomatic, and is not currently receiving corticosteroids for this condition; patients with leptomeningeal carcinoma (carcinomatous meningitis) are not eligible
- MESURABLE DISEASE: Any mass reproducibly measurable in two perpendicular dimensions, examples include:
- Pulmonary nodules
- Hepatic lesions
- Skin nodules (if two measurements can be assigned)
- Lymph nodes
- The following lesions do not qualify as measurable:
- Central nervous system (CNS) lesions
- Bone disease only; lytic lesions should be documented and followed
- Lymphangitic pulmonary metastases (patients with lymphangitic metastases are eligible if there are other sites of metastatic disease which can be measured)
- Lesions which have been irradiated unless there is definite documentation of progression since radiotherapy
- A baseline assessment of left ventricular ejection fraction within 8 weeks of registration is required (echocardiogram or resting multi gated acquisition scan [MUGA] (radionuclide cineangiography [RNCA]) nuclear scintigraphy); patients with a left ventricular ejection fraction (LVEF) < 45% are ineligible
- Granulocytes >= 1500/ul
- Platelet count >= 100,000/ul
- Creatinine =< 2.0 mg/dl
- Bilirubin within institutional normal limits
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST])
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase III Study of Paclitaxel Via Weekly 1 Hour Infusion Versus Standard 3 Hour Infusion Every 3 Weeks With Herceptin (Trastuzumab) (NSC #688097) in the Treatment of Patients With/Without HER-2/Neu-Overexpressing Metastatic Breast Cancer
This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether "dose dense" (DD) treatment with paclitaxel via weekly 1-hour infusion has a significantly higher response rate than "standard" (S) paclitaxel treatment, regardless of human epidermal growth factor receptor 2 (HER-2/neu) status and assignment to Herceptin (trastuzumab).
II. To determine if the addition of Herceptin to DD or S paclitaxel significantly improves the response rate as compared to DD or S paclitaxel alone for HER-2/neu non-overexpressing metastatic breast cancer (e.g., 0 or 1+).
III. To determine whether the addition of Herceptin to chemotherapy treatment modifies the quality of life experienced by patients with HER-2/neu non-overexpressing metastatic breast cancer.
IV. To determine whether the quality of life experienced by patients with metastatic breast cancer who have been treated with "standard" paclitaxel treatment differ from that of patients treated with "dose dense" paclitaxel treatment.
- To correlate amplification and overexpression of the growth factor receptor ErbB2 by immunohistochemistry and fluorescent in-situ hybridization (FISH) with response rate, time to progression, and overall survival of patients with metastatic breast cancer treated with paclitaxel chemotherapy and paclitaxel + Herceptin.
VI. To correlate ErbB2 shed extracellular domain (ECD) with response rate, time to progression, and overall survival of patients with metastatic breast cancer treated with different doses and schedules of paclitaxel and paclitaxel + Herceptin. In addition, to follow patterns of ErbB2/ECD after treatment and upon relapse.
SECONDARY OBJECTIVES:
- To evaluate time to progression and survival of patients with HER-2 overexpressing metastatic breast cancer treated with either DD or S paclitaxel plus weekly Herceptin.
II. To evaluate time to progression and survival of patients with HER-2 non-overexpressing metastatic breast cancer treated with either DD or S paclitaxel alone or DD or S paclitaxel plus weekly Herceptin.
III. To evaluate cardiac toxicity as measured by changes in LVEF from baseline to follow-up measurements.
OUTLINE; Patients are assigned to 1 of 2 treatment groups.
GROUP I (HER2/neu non-overexpressors): Patients are randomized to 1 of 4 treatment arms.
ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks.
ARM B: Patients receive paclitaxel IV over 1 hour weekly.
ARM C: Patients receive paclitaxel as in Arm A. Patients also receive trastuzumab IV weekly.
ARM D: Patients receive paclitaxel as in Arm B and trastuzumab as in Arm C.
GROUP II (HER2/neu overexpression): Patients are assigned to 1 of 2 treatment arms.
ARM E: Patients receive paclitaxel and trastuzumab as in Arm C.
ARM F: Patients receive paclitaxel and trastuzumab as in Arm D.
In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up periodically for up to 5 years.
- Conditions
- HER2-negative Breast Cancer, HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Being tested
- paclitaxel, trastuzumab, quality-of-life assessment, laboratory biomarker analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Anzatax, Asotax, TAX, Taxol
Given IV over 1 hour or 3 hours
trastuzumabBiological
Also called anti-c-erB-2, Herceptin, MOAB HER2
Given IV
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (paclitaxel) | Experimental | Patients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks. Receives: Drug: paclitaxel; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm B (paclitaxel) | Active comparator | Patients receive paclitaxel IV over 1 hour weekly. Receives: Drug: paclitaxel; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm C (paclitaxel, trastuzumab) | Experimental | Patients receive paclitaxel as in Arm I. Patients also receive trastuzumab IV weekly. Receives: Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm D (paclitaxel, trastuzumab) | Active comparator | Patients receive paclitaxel as in Arm II and trastuzumab as in Arm III. Receives: Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Am E (paclitaxel, trastuzumab) | Experimental | Patients receive paclitaxel and trastuzumab as in Arm C. Receives: Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
| Arm F (paclitaxel, trastuzumab) | Active comparator | Patients receive paclitaxel and trastuzumab as in Arm D. Receives: Drug: paclitaxel; Biological: trastuzumab; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (complete response [CR]) and partial response [PR])
Multivariate logistic regression will be used to relate patient characteristics and pretreatment clinical variables with tumor response (complete or partial). Interim analyses will use a chi square statistic to compare response incidence by treatment arm with two-sided bounds constructed from the O'Brien-Fleming approach
Measured: Up to 5 years
Secondary outcomes (7)
Overall survival
Kaplan-Meier curves will be plotted for each of the arms. Sets of curves will be compared using the logrank statistic. A Cox proportional hazards regression model will be used to relate length of survival with paclitaxel dose schedule, HER-2/neu status, Herceptin use (for HER-2/neu negatives), number of sites of metastases at baseline, ER status,
Measured: Up to 5 years
Time to disease progression:
Kaplan-Meier curves will be plotted for each combination of therapy. Sets of curves will be compared using the logrank statistic. A Cox proportional hazards regression model will be used to relate length of survival with paclitaxel dose schedule, HER-2/neu status, Herceptin use (for HER-2/neu negatives), number of sites of metastases at baseline, ER status, CALGB performance status, prior adjuvant chemotherapy, and prior radiotherapy.
Measured: Up to 5 years
Duration of response
For patients who achieve response within each arm, Kaplan-Meier curves will be used to estimate probability distributions for duration of response. Distributions will be compared using the logrank statistic.
Measured: Length of time between response and disease progression, assessed up to 5 years
Cardiac toxicity as measured by changes in LVEF
Cardiac toxicity will be evaluated using multivariate logistic regression.
Measured: From baseline to up to 5 years
Toxicity as assessed by CALGB Expanded Common Toxicity Criteria
Toxicity frequency will be tabulated by most severe occurrence.
Measured: Up to 5 years
Change in quality of life (QOL)
EORTC Breast Cancer Module QLQ-BR23, Changes in Function (C-616), Centers for Epidemiologic Studies-Depression (CES-d) Short Form (C-617), MOS Social Support Questionnaire (C-249), Spirituality Subscale (C-613) will be used to assess QOL. Multiple regression will be used to examine whether sociodemographic characteristics (age, gender, education, marital status, ethnicity, employment status); treatment (chemotherapy dose, Herceptin usage); clinical factors (HER2 status, performance status); and pre-treatment QOL, social support and spirituality, are significant predictors of survival.
Measured: From baseline to up to 9 months
Correlation between ErbB2 and response to treatment
Correlation will be assessed using contingency tables for two dichotomous variables, point biserial correlation for one dichotomous and one continuous variable and Pearson correlation for two dichotomous variables.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 1998
- Primary completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew Seidman, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003440
- Sponsor's protocol ID
- NCI-2012-02792
- Other IDs
- CALGB-9840, U10CA031946
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Paclitaxel Via Weekly 1 Hour Infusion Versus Standard 3 Hour Infusion Every 3 Weeks With Herceptin (Trastuzumab) (NSC #688097) in the Treatment of Patients With/Without HER-2/Neu-Overexpressing Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003440
- Acronym / sponsor ID
- NCI-2012-02792
- Conditions
- HER2-negative Breast Cancer, HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 1998
- Primary completion
- Jul 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether "dose dense" (DD) treatment with paclitaxel via weekly 1-hour infusion has a significantly higher response rate than "standard" (S) paclitaxel treatment, regardless of human epidermal growth factor receptor 2 (HER-2/neu) status and assignment to Herceptin (trastuzumab).
II. To determine if the addition of Herceptin to DD or S paclitaxel significantly improves the response rate as compared to DD or S paclitaxel alone for HER-2/neu non-overexpressing metastatic breast cancer (e.g., 0 or 1+).
III. To determine whether the addition of Herceptin to chemotherapy treatment modifies the quality of life experienced by patients with HER-2/neu non-overexpressing metastatic breast cancer.
IV. To determine whether the quality of life experienced by patients with metastatic breast cancer who have been treated with "standard" paclitaxel treatment differ from that of patients treated with "dose dense" paclitaxel treatment.
- To correlate amplification and overexpression of the growth factor receptor ErbB2 by immunohistochemistry and fluorescent in-situ hybridization (FISH) with response rate, time to progression, and overall survival of patients with metastatic breast cancer treated with paclitaxel chemotherapy and paclitaxel + Herceptin.
VI. To correlate ErbB2 shed extracellular domain (ECD) with response rate, time to progression, and overall survival of patients with metastatic breast cancer treated with different doses and schedules of paclitaxel and paclitaxel + Herceptin. In addition, to follow patterns of ErbB2/ECD after treatment and upon relapse.
SECONDARY OBJECTIVES:
- To evaluate time to progression and survival of patients with HER-2 overexpressing metastatic breast cancer treated with either DD or S paclitaxel plus weekly Herceptin.
II. To evaluate time to progression and survival of patients with HER-2 non-overexpressing metastatic breast cancer treated with either DD or S paclitaxel alone or DD or S paclitaxel plus weekly Herceptin.
III. To evaluate cardiac toxicity as measured by changes in LVEF from baseline to follow-up measurements.
OUTLINE; Patients are assigned to 1 of 2 treatment groups.
GROUP I (HER2/neu non-overexpressors): Patients are randomized to 1 of 4 treatment arms.
ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks.
ARM B: Patients receive paclitaxel IV over 1 hour weekly.
ARM C: Patients receive paclitaxel as in Arm A. Patients also receive trastuzumab IV weekly.
ARM D: Patients receive paclitaxel as in Arm B and trastuzumab as in Arm C.
GROUP II (HER2/neu overexpression): Patients are assigned to 1 of 2 treatment arms.
ARM E: Patients receive paclitaxel and trastuzumab as in Arm C.
ARM F: Patients receive paclitaxel and trastuzumab as in Arm D.
In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A (paclitaxel) | Experimental | Drug: paclitaxel, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive paclitaxel intravenously (IV) over 3 hours every 3 weeks. |
| Arm B (paclitaxel) | Active comparator | Drug: paclitaxel, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive paclitaxel IV over 1 hour weekly. |
| Arm C (paclitaxel, trastuzumab) | Experimental | Drug: paclitaxel, Biological: trastuzumab, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive paclitaxel as in Arm I. Patients also receive trastuzumab IV weekly. |
| Arm D (paclitaxel, trastuzumab) | Active comparator | Drug: paclitaxel, Biological: trastuzumab, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive paclitaxel as in Arm II and trastuzumab as in Arm III. |
| Am E (paclitaxel, trastuzumab) | Experimental | Drug: paclitaxel, Biological: trastuzumab, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive paclitaxel and trastuzumab as in Arm C. |
| Arm F (paclitaxel, trastuzumab) | Active comparator | Drug: paclitaxel, Biological: trastuzumab, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive paclitaxel and trastuzumab as in Arm D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed adenocarcinoma of the female breast which is inoperable, recurrent or metastatic
- HER-2/neu status must be known at the time of protocol registration; HER-2/neu assessment will be based on FISH analysis of either the primary tumor or a metastatic site; a scoring of 0 or 1+ by immunohistochemistry (IHC) is considered negative; 2+ is considered negative unless confirmed by FISH positivity, in which case it should be considered positive; 3+ by IHC is considered positive; for centers using FISH only, a positive FISH assay by itself is sufficient to determine HER-2 positivity
- Patients with the following prior therapy are eligible:
- Prior Herceptin therapy is not allowed
- Patients with central nervous system metastases are eligible only if the patient has completed cranial irradiation at least 6 months prior, is currently asymptomatic, and is not currently receiving corticosteroids for this condition; patients with leptomeningeal carcinoma (carcinomatous meningitis) are not eligible
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelAlso: Anzatax, Asotax, TAX, TaxolGiven IV over 1 hour or 3 hours | Drug | Am E (paclitaxel, trastuzumab), Arm A (paclitaxel), Arm B (paclitaxel), Arm C (paclitaxel, trastuzumab), Arm D (paclitaxel, trastuzumab), Arm F (paclitaxel, trastuzumab) |
| trastuzumabAlso: anti-c-erB-2, Herceptin, MOAB HER2Given IV | Biological | Am E (paclitaxel, trastuzumab), Arm C (paclitaxel, trastuzumab), Arm D (paclitaxel, trastuzumab), Arm F (paclitaxel, trastuzumab) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Am E (paclitaxel, trastuzumab), Arm A (paclitaxel), Arm B (paclitaxel), Arm C (paclitaxel, trastuzumab), Arm D (paclitaxel, trastuzumab), Arm F (paclitaxel, trastuzumab) |
| laboratory biomarker analysisCorrelative studies | Other | Am E (paclitaxel, trastuzumab), Arm A (paclitaxel), Arm B (paclitaxel), Arm C (paclitaxel, trastuzumab), Arm D (paclitaxel, trastuzumab), Arm F (paclitaxel, trastuzumab) |
Primary outcome
Response rate (complete response [CR]) and partial response [PR])
Time frame: Up to 5 years
Multivariate logistic regression will be used to relate patient characteristics and pretreatment clinical variables with tumor response (complete or partial). Interim analyses will use a chi square statistic to compare response incidence by treatment arm with two-sided bounds constructed from the O'Brien-Fleming approach
7 secondary outcomes
Overall survival
Time frame: Up to 5 years
Time to disease progression:
Time frame: Up to 5 years
Duration of response
Time frame: Length of time between response and disease progression, assessed up to 5 years
Cardiac toxicity as measured by changes in LVEF
Time frame: From baseline to up to 5 years
Toxicity as assessed by CALGB Expanded Common Toxicity Criteria
Time frame: Up to 5 years
Change in quality of life (QOL)
Time frame: From baseline to up to 9 months
Correlation between ErbB2 and response to treatment
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Seidman principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paclitaxel, trastuzumab and quality-of-life assessment in people with HER2-negative Breast Cancer and HER2-positive Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (complete response [CR]) and partial response [PR]) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.