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Stages I, II, and III HER2-Negative Hormone Receptor–Positive Breast Cancer
Source: Breast Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Context: Systemic Therapy for Stages I, II, and III Breast Cancer
Most studies that support the use of chemotherapy were conducted after patients had surgery and prior to the widespread use of preoperative therapy. In general, their results are still applicable to preoperative treatment, and these regimens are the ones most commonly used in the neoadjuvant space for this subtype. The following section describes studies that examined the use of chemotherapy in the preoperative setting.
Early trials examined whether anthracycline-based regimens used in the adjuvant setting would prolong DFS and OS when used in the preoperative setting. The evidence supports higher rates of breast-conserving therapy with the use of a preoperative anthracycline chemotherapy regimen than with postoperative use, but no improvement in survival was noted with the preoperative strategy.
Typically, an anthracycline-and-taxane–based regimen is used if chemotherapy is administered in the neoadjuvant setting for patients with HER2-negative breast cancer.
Evidence (anthracycline/taxane–based chemotherapy regimen):
In an effort to improve on the results observed with doxorubicin and cyclophosphamide (AC) alone, the NSABP B-27 trial (NCT00002707) was conducted. Patients were randomly assigned to receive (1) four cycles of preoperative AC followed by surgery, (2) four cycles of AC followed by four cycles of docetaxel and then surgery, or (3) four cycles of AC followed by surgery and then four cycles of docetaxel.[13][Level of evidence B1]
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In an effort to improve on the results observed with doxorubicin and cyclophosphamide (AC) alone, the NSABP B-27 trial (NCT00002707) was conducted. Patients were randomly assigned to receive (1) four cycles of preoperative AC followed by surgery, (2) four cycles of AC followed by four cycles of docetaxel and then surgery, or (3) four cycles of AC followed by surgery and then four cycles of docetaxel.[13][Level of evidence B1]
The administration of preoperative AC followed by docetaxel was associated with a higher clinical complete response rate compared with the administration of AC alone (63.6% for AC followed by docetaxel and 40.1% for AC alone; P < .001); a higher pCR rate was also observed (26.1% for AC followed by docetaxel and 13.7% for AC alone; P < .001).
Data from NSABP B-27 and the Aberdeen Breast Group Trial support the use of anthracycline/taxane–based regimens in women with initial response or with relative resistance to anthracyclines.[11]
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Alternative anthracycline/taxane schedules have also been evaluated (concurrent docetaxel, doxorubicin, and cyclophosphamide) and appear similar in efficacy to the sequential approach described above.[14][Level of evidence B3]
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The phase III GeparSepto trial (NCT01583426) investigated an alternative taxane (nab-paclitaxel) in patients with untreated primary breast cancer.[15] Patients (n = 1,229) were randomly assigned to receive 12 weeks of nab-paclitaxel or paclitaxel followed by epirubicin and cyclophosphamide for four cycles.
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The phase III GeparSepto trial (NCT01583426) investigated an alternative taxane (nab-paclitaxel) in patients with untreated primary breast cancer.[15] Patients (n = 1,229) were randomly assigned to receive 12 weeks of nab-paclitaxel or paclitaxel followed by epirubicin and cyclophosphamide for four cycles.
The pCR rate was higher in the nab-paclitaxel arm (233 patients, 38%; 95% CI, 35%–42%) when compared with the paclitaxel arm (174 patients, 29%; 95% CI, 25%–33%).[15][Level of evidence B3]
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The phase III GeparSepto trial (NCT01583426) investigated an alternative taxane (nab-paclitaxel) in patients with untreated primary breast cancer.[15] Patients (n = 1,229) were randomly assigned to receive 12 weeks of nab-paclitaxel or paclitaxel followed by epirubicin and cyclophosphamide for four cycles.
However, in the ETNA trial (NCT01822314) that compared neoadjuvant nab-paclitaxel with paclitaxel followed by anthracycline-based therapy, no significant difference in pCR was observed, and neutropenia and peripheral neuropathy were more frequent in the nab-paclitaxel arm.[16]
The phase III GeparSepto trial (NCT01583426) investigated an alternative taxane (nab-paclitaxel) in patients with untreated primary breast cancer.[15] Patients (n = 1,229) were randomly assigned to receive 12 weeks of nab-paclitaxel or paclitaxel followed by epirubicin and cyclophosphamide for four cycles.
Differences in taxane dose and schedule may explain the different findings in the GeparSepto and ETNA trials.
The incorporation of other cytotoxic agents to anthracycline/taxane–based regimens has not offered a significant additional benefit to breast conservation or pCR rate in unselected breast cancer populations.[17][Level of evidence B3]
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Preserved source evidence · Not medical advice