Trial · NCT00432172
Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
NCT00432172, Phase 2, Completed, Spanish Breast Cancer Research Group; results first posted 2019-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients. Trials, record NCT00432172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00432172
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients
- NCT number
- NCT00432172
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 189 participants, actual
- Lead sponsor
- Spanish Breast Cancer Research Group
- Conditions
- Breast Cancer
- Interventions
- Epirubicin, Cyclophosphamide, Docetaxel, Exemestane, Goserelin, Carboplatin
- First posted
- 2007-02-07
- Last updated
- 2023-04-03
- Results first posted
- 2019-07-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Response for Basal Group 2 | Up to 24 weeks | This primary outcome only applies for the basal group 2 as per protocol. The pathological response in luminal group 1 was not pre-specified even as a Secondary Outcome. Pathological response was assessed after surgery, according to the Miller \& Payne criteria, which stratifies the responses based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in breast and axilla. Grades 1-4 are categorised as a partial pathological response (pPR) and grade 5 was a complete pathological response (cPR). |
| Secondary | Clinical Response Rate | Up to week 24 | Clinical Response Rate was measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria for target lesions before surgery: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Breast Conservative Surgery Rate | Up to 24 weeks | All patients will undergo surgery within the expected period from the end of treatment with neoadjuvant therapy. The chosen surgical option will be collected in the Case Report Form (CRF) before starting the neoadjuvant treatment, depending on the characteristics Clinics of the patient at that time (conservative surgery or mastectomy). This information will be compared with definitive surgery, to analyze whether neoadjuvant treatment has contributed to increase the rate of conservative surgery. |
| Secondary | Axillary Node Status at the Time of Surgery | Up to 24 weeks | All the patients underwent lymphadenectomy in the foreseen term from the end of the treatment with neoadjuvant therapy, except for patients who underwent the technique of Sentinel lymph node with negative result before the start of the study treatment. Clinical lymph node involvement were collected in the CRF. Behind the lymphadenectomy, the rate of patients with affected lymph nodes, regardless of the type of response in the breast. To help find out if the cancer has spread outside the breast, one or more of the lymph nodes in the axilla (axillary lymph nodes) are removed for examination under a microscope. This is an important part of the determination of the stage. When the lymph nodes have cancer cells, there is a greater chance that the cancer cells have spread to other parts of the body. Decisions about treatment will depend on whether there is cancer in the lymph nodes. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathological Response for Basal Group 2 | Up to 24 weeks | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Response Rate | Up to week 24 | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Breast Conservative Surgery Rate | Up to 24 weeks | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Axillary Node Status at the Time of Surgery | Up to 24 weeks | For Group 2 (Basal) selective treatment: there was one patient who did not receive treatment, because of this is not included on the final analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathological Response for Basal Group 2 | Group 2 (Basal) Standard Treatment | Grade 5 | 16 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Selective Treatment | Grade 5 | 14 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Standard Treatment | Grade 4 | 5 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Selective Treatment | Grade 4 | 11 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Standard Treatment | Grade 3 | 11 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Selective Treatment | Grade 3 | 8 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Standard Treatment | Grade 2 | 8 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Selective Treatment | Grade 2 | 9 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Standard Treatment | Grade 1 | 5 | Participants | |
| Pathological Response for Basal Group 2 | Group 2 (Basal) Selective Treatment | Grade 1 | 4 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (Luminal A) Standard Treatment | 47 | |
| Overall Study | STARTED | Group 1 (Luminal A) Selective Treatment | 48 | |
| Overall Study | STARTED | Group 2 (Basal) Standard Treatment | 46 | |
| Overall Study | STARTED | Group 2 (Basal) Selective Treatment | 48 | |
| Overall Study | COMPLETED | Group 1 (Luminal A) Standard Treatment | 41 | |
| Overall Study | COMPLETED | Group 1 (Luminal A) Selective Treatment | 41 | |
| Overall Study | COMPLETED | Group 2 (Basal) Standard Treatment | 35 | |
| Overall Study | COMPLETED | Group 2 (Basal) Selective Treatment | 41 | |
| Overall Study | NOT COMPLETED | Group 1 (Luminal A) Standard Treatment | 6 | |
| Overall Study | NOT COMPLETED | Group 1 (Luminal A) Selective Treatment | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 1 (Luminal A) Standard Treatment | 5 | 45 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 1 (Luminal A) Selective Treatment | 0 | 46 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 2 (Basal) Standard Treatment | 2 | 46 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 2 (Basal) Selective Treatment | 4 | 47 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 1 (Luminal A) Standard Treatment | 1 | 45 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 1 (Luminal A) Selective Treatment | 0 | 46 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 2 (Basal) Standard Treatment | 2 | 46 | |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Group 2 (Basal) Selective Treatment | 2 | 47 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Group 1 (Luminal A) Standard Treatment | 5 | 45 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Group 1 (Luminal A) Selective Treatment | 0 | 46 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (Luminal A) Standard Treatment | 0 | 45 |
| Total, all-cause mortality | Group 1 (Luminal A) Selective Treatment | 0 | 46 |
| Total, all-cause mortality | Group 2 (Basal) Standard Treatment | 0 | 46 |
| Total, all-cause mortality | Group 2 (Basal) Selective Treatment | 0 | 47 |
| Total, other adverse events | Group 1 (Luminal A) Standard Treatment | 45 | 45 |
| Total, other adverse events | Group 1 (Luminal A) Selective Treatment | 46 | 46 |
| Total, other adverse events | Group 2 (Basal) Standard Treatment | 46 | 46 |
| Total, other adverse events | Group 2 (Basal) Selective Treatment | 47 | 47 |
| Total, serious adverse events | Group 1 (Luminal A) Standard Treatment | 5 | 45 |
| Total, serious adverse events | Group 1 (Luminal A) Selective Treatment | 0 | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00432172
GET https://conductscience.org/api/trials/v1/NCT00432172/results?page=2