Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00129376|
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).
The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel||Phase 2|
Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176). Adjuvant chemotherapy and radiotherapy were delivered according to the protocol of each participating center. Hormonal treatment was started after the last chemotherapy infusion in all patients with positive estrogen and/or progesterone receptor tumors and was continued for five years.
Semiquantitative determination of three molecular markers was carried out by immunocytochemical methods. Tissue samples were taken prior to initiation of chemotherapy from the core of the primary tumors. Specimens were sent to a central laboratory for analysis of Topo II, survivin and p27.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients|
|Actual Study Start Date :||February 2003|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||February 2010|
Experimental: Doxorubicin+cyclophosphamide - Docetaxel
Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles. Later, docetaxel (36 mg/m2) was administered an intravenous infusion, weekly for six weeks followed by a 2-week resting period (8-week cycle).
Other Name: adriamycin
Other Name: Cytoxan
Other Name: Taxotere
- Pathological Complete Response (pCR) Rate [ Time Frame: Up to 29 weeks ]Pathological complete response was defined by the Miller & Payne criteria. pCR was defined as no invasive cells identifiable in breast sections at surgery. Response was measured by physical exam and breast imaging before surgery and was evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, was based on the proportion of remaining tumor and postchemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
- Clinical Response Rate (CRR) [ Time Frame: Up to 29 weeks ]
CRR measured according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, where:
- Complete Response (CR): disappearance of all target lesions
- Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions
- Progresive Disease (PD): >=20% increase from smallest sum of longest diameter recorded since treatment started (best response).
- Stable Disease (SD): Neither PD nor PR
- Number of Participants With Over-expression of Topo II (>10% Cells With Nuclear Staining) [ Time Frame: Up to 29 weeks ]Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Over-expression of Topo II was defined as >10% cells with nuclear staining.
- Number of Participants With Over-expression of Survivin (>1% Cells With Nuclear Staining) [ Time Frame: Up to 29 weeks ]Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Tumors with more than 1% of cells with nuclear staining were considered to be over-expressing this protein.
- Number of Participants With Over-expression of p27 (>75% Cells With Nuclear Staining) [ Time Frame: Up to 29 weeks ]Paraffin-embedded tumors were processed with standard immunocytochemical techniques. Sections were rated according to the percentage of tumor cells nuclei with positive staining (1 = < 25%; 2 = between 25-75% and 3 = > 75%).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129376
|Hospital Universitario Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Corporació Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital de la Ribera|
|Alcira, Valencia, Spain, 46600|
|Complejo Hospitalario Universitario A Coruña|
|A Coruña, Spain, 15006|
|Hospital General Universitario de Alicante|
|Alicante, Spain, 03010|
|Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Study Director:||Study Director||Fundación Jiménez Díaz|
|Study Director:||Study Director||Hospital Universitario Marqués de Valdecilla|