Trial Outcomes & Findings for Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients (NCT NCT00432172)

Last Updated: 2023-04-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

189 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2023-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 (Luminal A) Standard Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 1 (Luminal A) Selective Treatment Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months	Group 2 (Basal) Standard Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Overall Study STARTED	47	48	46	48
Overall Study COMPLETED	41	41	35	41
Overall Study NOT COMPLETED	6	7	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (Luminal A) Standard Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 1 (Luminal A) Selective Treatment Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months	Group 2 (Basal) Standard Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Overall Study Physician Decision	0	0	2	0
Overall Study Adverse Event	4	2	4	3
Overall Study Disease progression	0	2	5	1
Overall Study Withdrawal by Subject	0	1	0	2
Overall Study No treatment received	2	2	0	1

Baseline Characteristics

Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (Luminal A) Standard Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 1 (Luminal A) Selective Treatment n=48 Participants Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months	Group 2 (Basal) Standard Treatment n=46 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=48 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.	Total n=189 Participants Total of all reporting groups
Age, Continuous	51 years n=5 Participants	50.5 years n=7 Participants	47 years n=5 Participants	47 years n=4 Participants	49 years n=21 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	48 Participants n=7 Participants	46 Participants n=5 Participants	48 Participants n=4 Participants	189 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Menopausal status Premenopausal	24 Participants n=5 Participants	27 Participants n=7 Participants	33 Participants n=5 Participants	29 Participants n=4 Participants	113 Participants n=21 Participants
Menopausal status Postmenopausal	23 Participants n=5 Participants	21 Participants n=7 Participants	13 Participants n=5 Participants	19 Participants n=4 Participants	76 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 0	43 Participants n=5 Participants	47 Participants n=7 Participants	38 Participants n=5 Participants	44 Participants n=4 Participants	172 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 1	4 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Histologic type Ductal	38 Participants n=5 Participants	39 Participants n=7 Participants	39 Participants n=5 Participants	41 Participants n=4 Participants	157 Participants n=21 Participants
Histologic type Lobular	4 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Histologic type Other	5 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Histological grade Grade 1	11 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	25 Participants n=21 Participants
Histological grade Grade 2	30 Participants n=5 Participants	27 Participants n=7 Participants	9 Participants n=5 Participants	13 Participants n=4 Participants	79 Participants n=21 Participants
Histological grade Grade 3	6 Participants n=5 Participants	10 Participants n=7 Participants	36 Participants n=5 Participants	33 Participants n=4 Participants	85 Participants n=21 Participants
Tumor size T1	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants
Tumor size T2	36 Participants n=5 Participants	34 Participants n=7 Participants	34 Participants n=5 Participants	31 Participants n=4 Participants	135 Participants n=21 Participants
Tumor size T3	10 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	41 Participants n=21 Participants
Tumor size T4	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Nodal status N0	24 Participants n=5 Participants	28 Participants n=7 Participants	21 Participants n=5 Participants	24 Participants n=4 Participants	97 Participants n=21 Participants
Nodal status N1	22 Participants n=5 Participants	19 Participants n=7 Participants	22 Participants n=5 Participants	20 Participants n=4 Participants	83 Participants n=21 Participants
Nodal status N2	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Group 2 (Basal) Standard Treatment n=46 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.	Group 2 (Basal) Standard Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Pathological Response for Basal Group 2 Not available	1 Participants	1 Participants	—	—
Pathological Response for Basal Group 2 Grade 5	16 Participants	14 Participants	—	—
Pathological Response for Basal Group 2 Grade 4	5 Participants	11 Participants	—	—
Pathological Response for Basal Group 2 Grade 3	11 Participants	8 Participants	—	—
Pathological Response for Basal Group 2 Grade 2	8 Participants	9 Participants	—	—
Pathological Response for Basal Group 2 Grade 1	5 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: Up to week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 2 (Basal) Standard Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=48 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.	Group 2 (Basal) Standard Treatment n=46 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Clinical Response Rate	31 Participants	23 Participants	32 Participants	36 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 2 (Basal) Standard Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=48 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.	Group 2 (Basal) Standard Treatment n=46 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Breast Conservative Surgery Rate Breast conservative surgery	22 Participants	27 Participants	31 Participants	34 Participants
Breast Conservative Surgery Rate Non Breast conservative surgery	23 Participants	17 Participants	15 Participants	13 Participants
Breast Conservative Surgery Rate Not available	2 Participants	4 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Group 2 (Basal) Standard Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=48 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.	Group 2 (Basal) Standard Treatment n=46 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=47 Participants Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Axillary Node Status at the Time of Surgery Negative nodes	15 Participants	14 Participants	31 Participants	32 Participants
Axillary Node Status at the Time of Surgery No Negative nodes	29 Participants	28 Participants	13 Participants	13 Participants
Axillary Node Status at the Time of Surgery Not available	3 Participants	6 Participants	2 Participants	2 Participants

Adverse Events

Group 1 (Luminal A) Standard Treatment

Serious events: 5 serious events

Other events: 45 other events

Deaths: 0 deaths

Group 1 (Luminal A) Selective Treatment

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Group 2 (Basal) Standard Treatment

Serious events: 16 serious events

Other events: 46 other events

Deaths: 0 deaths

Group 2 (Basal) Selective Treatment

Serious events: 9 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 (Luminal A) Standard Treatment n=45 participants at risk Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 1 (Luminal A) Selective Treatment n=46 participants at risk Postmenopausal patients: exemestane x 6 months Premenopausal patients: goserelin x 6 months + exemestane x 6 months	Group 2 (Basal) Standard Treatment n=46 participants at risk Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.	Group 2 (Basal) Selective Treatment n=47 participants at risk Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles.
Infections and infestations Febrile neutropenia	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Hepatobiliary disorders Pancreatitis	2.2% 1/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Infections and infestations Infection pulmonary/ Upper airway NOS	2.2% 1/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Infections and infestations Infection - Port a cath infection	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Gastrointestinal disorders Diarrhea	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Infections and infestations Infection - Lung (pneumonia)	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Infections and infestations Infection - septic shock	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Gastrointestinal disorders Mucositis/stomatitis and Vomiting	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Endocrine disorders Diabetes decompensation	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Growth and abcessification of the tumor and cellulitis	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.2% 1/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Infections and infestations Infection with unknown ANC - Cellulitis	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.1% 1/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.
Investigations Surgical intervention at left upper extremity	0.00% 0/45 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	0.00% 0/46 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.	2.1% 1/47 • Through study treatment up to surgery, an average of 21 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. For Group 1 (Luminal A) Standard Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis. For Group 1 (Luminal A) Selective Treatment: there were two patients who did not receive treatment, because of this, are not included on the final analysis.

Other adverse events

Additional Information

Scientific Director / Medical Lead / Project Manager

Spanish Breast Cancer Research Group

Phone: +34916592870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60