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. 2020 Nov 2;15(6):608–618. doi: 10.1159/000511925

Therapy Algorithms for the Diagnosis and Treatment of Patients with Early and Advanced Breast Cancer

Andreas Schneeweiss a,*, Ingo Bauerfeind b, Tanja Fehm c, Wolfgang Janni d, Christoph Thomssen e, Isabell Witzel f, Achim Wöckel g, Volkmar Müller f
PMCID: PMC7768141  PMID: 33447235

Abstract

Background

In order to offer optimal treatment approaches based on available evidence, the Commission Breast of the Working Group Gynecologic Oncology (AGO) of the German Cancer Society developed therapy algorithms for eight complex treatment situations in primary and advanced breast cancer.

Summary

Therapy algorithms for the following complex treatment situations are outlined in this paper: (neo)adjuvant therapy of human epidermal growth factor receptor 2 (HER2)-positive breast cancer; axillary surgery and neoadjuvant chemotherapy; adjuvant endocrine therapy in premenopausal patients; adjuvant endocrine therapy in postmenopausal patients; hormone receptor (HR)-positive/HER2-negative metastatic breast cancer: strategies; HR-positive/HER2-negative metastatic breast cancer: endocrine-based first-line treatment; HER2-positive metastatic breast cancer: first to third-line; metastatic triple-negative breast cancer.

Key Messages

The therapy options shown in these algorithms are based on the current AGO recommendations updated in January 2020 but cannot represent all evidence-based treatment options. Prior therapies, performance status, comorbidities, patient preference, etc. must be taken into account for the actual treatment choice. Therefore, in individual cases, other evidence-based treatment options not listed here may also be appropriate and justified.

Keywords: Breast cancer guidelines, Therapy algorithms, Evidence-based treatment

Introduction

On the basis of the current Working Group Gynecologic Oncology (AGO) recommendations for the diagnosis and treatment of patients with early and advanced breast cancer updated in January 2020, a task force consisting of eight members of the Commission Breast of the AGO developed drafts for eight therapy algorithms of complex treatment situations in patients with early and advanced breast cancer. Those drafts were then discussed and finally approved by all active members of the Commission Breast of the AGO in virtual meetings. The members of the Commission Breast are completely aware of many other complex treatment situations for which such therapy algorithms are needed. Depending on the usefulness and usage of the algorithms outlined in this paper, the development of further algorithms is planned. The definitions of AGO grades of recommendation are listed in Table 1. Figure 1 shows the formats used in the algorithms.

Table 1.

AGO grades of recommendation

AGO grade of recommendation Definition
++ this investigation or therapeutic intervention is highly beneficial for patients, can be recommended without restriction, and should be performed
+ this investigation or therapeutic intervention is of limited benefit for patients and can be performed
+/− this investigation or therapeutic intervention has not shown benefit for patients and may be performed only in individual cases; according to current knowledge a general recommendation cannot be given
− this investigation or therapeutic intervention can be of disadvantage for patients and might not be performed
− − this investigation or therapeutic intervention is of clear disadvantage for patients and should be avoided or omitted in any case
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AGO, Working Group Gynecologic Oncology

Fig. 1.

Fig. 1

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Format legend.

(Neo)Adjuvant Therapy of HER2-Positive Breast Cancer (Fig. 2)

Fig. 2.

Fig. 2

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(Neo)adjuvant therapy of HER2-positive breast cancer.

Human epidermal growth factor receptor 2 (HER2)-positive breast cancer clinical stage T1 N0, confirmed following surgery as pT1 pN0, should receive a de-escalated adjuvant therapy with 12 doses of paclitaxel weekly plus trastuzumab (Tz) for 1 year (AGO grade of recommendation + [AGO+]) [1]. If pathological T or N stage are higher, patients should receive a full-term adjuvant Tz-based regimen (if pN0, AGO++) [2, 3] or a pertuzumab (Pz) plus Tz-based regimen (AGO+) [4, 5]. In case of hormone receptor (HR)-positive, HER2-positive breast cancer, extended adjuvant treatment with neratinib might be discussed only following a Tz-containing Pz-free adjuvant therapy (AGO+) [6]. In all other cases, if systemic chemotherapy is indicated, patients with HER2-positive breast cancer should receive a full-term Pz plus Tz-based neoadjuvant systemic therapy for 6–8 cycles (AGO++) [7, 8]. In case of pathological complete response (pCR), defined as ypT0/is and ypN0, continuation of the anti-HER2 antibody therapy is recommended up to the completion of 1 year. In patients with pCR and negative lymph nodes before and after neoadjuvant systemic therapy, Tz monotherapy might be sufficient (AGO++) [9]. In patients with lymph node involvement prior to neoadjuvant systemic therapy, dual HER2 blockade with Tz plus Pz is recommended despite pCR (AGO+). Patients who have residual invasive disease in the breast or lymph nodes following optimal neoadjuvant systemic therapy including a taxane and at least Tz for 9 weeks should receive 14 cycles of trastuzumab emtansine (T-DM1) as adjuvant treatment (AGO+) [10].

Axillary Surgery and Neoadjuvant Chemotherapy (Fig. 3)

Fig. 3.

Fig. 3

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Axillary surgery and neoadjuvant chemotherapy.

Sentinel lymph node biopsy (SLNB) should be performed after neoadjuvant chemotherapy (NACT) (AGO+) [11, 12, 13, 14, 15, 16]. In case of clinical and sonographic negative axillary lymph nodes before and after NACT, SLNB is the axillary staging method of choice. If no sentinel lymph node (SLN) shows tumor involvement, further axillary interventions are not indicated (AGO++). In case of positive SLN after NACT, axillary lymph node dissection is strongly recommended (AGO++). Also in case of histologically proven micrometastatic SLN involvement after NACT (ypN1micSN), axillary lymph node dissection should be performed (AGO+) because low-volume SLN disease after NACT is not an indicator of a low risk of additional positive axillary nodes [17]. Prospective survival data are lacking [18]. Clinically lymph node involvement before NACT should be verified by core needle biopsy. It is recommended to tag those lymph nodes (AGO+). If lymph node status is converted to clinically node-negative after NACT, targeted axillary dissection is preferred because false-negative rates are reported to be <10% [16, 17]. A sole SLNB in these situations causes false-negative rates between 12 and 14% and does not allow adequate stratification of post-neoadjuvant treatment [11, 12, 13, 14, 15, 19]. SLNB before NACT is possible in clinically lymph node-negative patients but not recommended (AGO+/−). The SENTINA trial reported 30% of tumor-involved lymph nodes in clinically lymph node-negative patients before NACT. In case of SLN involvement before NACT, evidence-based subsequent procedures have not been evaluated yet. Therefore, SLNB should be performed after NACT.

Adjuvant Endocrine Therapy in Breast Cancer Patients (Fig. 4a, b)

Fig. 4.

Fig. 4

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Adjuvant endocrine therapy. a Premenopausal patients. b Postmenopausal patients.

Patients with estrogen receptor-positive breast cancer should receive adjuvant endocrine treatment. In pre- or perimenopausal patients, standard treatment includes tamoxifen for at least 5 years (AGO++) [20]. In patients with higher risk of recurrence (e.g., pN+), extended adjuvant treatment with either tamoxifen for further 5 years, if still premenopausal (AGO++), or aromatase inhibitor (AI) for 2–5 years, if postmenopausal after 5 years of endocrine treatment (AGO+), should be recommended [21, 22]. Adding ovarian suppression with gonadotropin-releasing hormone agonists (GnRHa) might be an option for patients who received chemotherapy and regain ovarian function within 2 years after the end of chemotherapy. Ovarian function is defined by menstruation, or estradiol or follicle stimulating hormone levels in the pre- or perimenopausal range. In patients 35 years or older who regain ovarian function, GnRHa should be added to tamoxifen for 5 years (AGO+) [23]. In patients under 35 years of age, tamoxifen plus GnRHa (AGO++) or AI plus GnRHa (AGO+) for 5 years are options [23, 24]. All patients who received chemotherapy and are premenopausal after 5 years should receive extended adjuvant treatment with tamoxifen for further 5 years (AGO+) [21].

In postmenopausal patients the standard treatment includes an AI. Only very old patients and patients with a very low risk of recurrence or with contraindications for AI can receive tamoxifen only for 5 years (AGO+) [20]. Extended adjuvant treatment with tamoxifen for further 5 years might be discussed [21]. In all other cases, patients should receive tamoxifen for 2–3 years followed by AI (for a total of 5 years) or AI for 2–3 years followed by tamoxifen (for a total of 5 years) or AI for 5 years (AGO++) [25]. In patients with invasive lobular histology, a nonsteroidal AI for 5 years might be discussed (AGO+) [25]. In patients with high risk of recurrence, extended adjuvant treatment with an AI for 2–5 years should be recommended (AGO+) [26]. The decision criteria for the definition of high risk of recurrence may include (neo)adjuvant chemotherapy (indicating high risk), positive lymph node status, T2/T3 tumors, and elevated risk of recurrence based on immunohistochemical criteria or based on multi-gene expression assays or high CTS5 score.

HR-Positive/HER2-Negative Metastatic Breast Cancer: Strategies (Fig. 5a)

Fig. 5.

Fig. 5

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HR-positive/HER2-negative metastatic breast cancer. a Strategies. b Endocrine-based first-line therapy.

Recent evidence has resulted in additional therapeutic options for the treatment of advanced or metastatic HR-positive and HER2-negative breast cancer. In order to reach the therapeutic goal of maintaining a quality of life as high as possible, today the first-line standard of care therapy is endocrine-based combination with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor (abemaciclib, palbociclib, ribociclib) plus endocrine therapy (AI or fulvestrant) (AGO++) [27, 28]. Only if a very rapid response is required due to severe symptoms or imminent organ failure, cytostatic drugs (AGO++), if necessary combined with bevacizumab (AGO+), should be used as first-line therapy [29, 30, 31, 32]. Second-line therapy options depend on the extent of progression, the need for response, and the patient's preference. In case of a BRCA1/2 germline mutation, therapy with poly(ADP-ribose)-polymerase (PARP) inhibitors can be offered as a valuable treatment option (AGO+) [33, 34, 35, 36, 37, 38, 39]. In addition, further single-agent or combination therapies are available. Besides the combination with everolimus, alpelisib will also be a future therapeutic option in case of PIK3CA mutation (AGO+) [40, 41]. In case of endocrine resistance, cytotoxic drugs should be offered as further therapy (AGO+) [42].

HR-Positive/HER2-Negative Metastatic Breast Cancer: Endocrine-Based First-Line Therapy (Fig. 5b)

Data from the PALOMA, MONALEESA, and MONARCH studies showed significant and clinically relevant improvements of progression-free survival in pre-, peri-, and postmenopausal patients if CDK4/6 inhibitors have been used (AGO++) [43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59]. Currently, mature data regarding overall survival are only available for individual CDK4/6 inhibitors in defined situations. If CDK4/6 inhibitors are not administered, the initial approach in premenopausal patients is to suppress ovarian function (e.g., with GnRHa) combined with tamoxifen (AGO++) [60, 61]. In case of tumor progression on tamoxifen or if tamoxifen is contraindicated, a third-generation AI plus GnRHa can be administered (AGO+). In addition, fulvestrant plus GnRHa can be considered as a further option (AGO+) [62, 63, 64, 65]. Depending on the previous adjuvant therapy, in postmenopausal patients AI and tamoxifen can be administered (AGO+) [66, 67, 68, 69, 70, 71, 72]. In particular after previous treatment with an AI, treatment with fulvestrant should be considered (AGO+) [73, 74, 75].

HER2-Positive Metastatic Breast Cancer: First to Third Line (Fig. 6)

Fig. 6.

Fig. 6

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HER2-positive metastatic breast cancer: first to third line.

In the first-line setting, patients with HER2-positive metastatic breast cancer (treatment-free interval >6 months or previously untreated with anti-HER2 targeted therapy) should be treated with a taxane and dual blockade of the HER2 receptor by Tz and Pz (AGO++) [76]. If patients are HR-positive, a switch to endocrine treatment and dual blockade as maintenance therapy may be considered after successful induction chemotherapy, although this strategy has not been evaluated in randomized clinical trials. In case of progressive disease, T-DM1 is an established second-line treatment (AGO++) [77, 78]. For third or higher lines of treatment, no standard regimens are defined. Therefore, patients should be encouraged to participate in clinical trials investigating new experimental anti-HER2 drugs (AGO+). Otherwise, capecitabine plus lapatinib [79, 80] chemotherapy plus Tz [81], Tz plus Pz [82], or lapatinib plus Tz [83, 84] may be therapeutic options to be discussed with the patient (AGO+). If patients have previously been treated with HER2 targeted therapy including Tz with or without Pz in the (neo)adjuvant setting and the treatment-free interval is <6 months, T-DM1 as a first-line treatment should be considered (AGO+) followed by third-line options in case of disease progression. No established regimens are available for those metastatic patients who have received T-DM1 in the adjuvant setting after neoadjuvant Tz plus Pz and no pCR. Therefore, third-line options may be offered to these heavily HER2-pretreated patients. For triple-positive patients who are unsuitable for chemotherapy or prefer chemotherapy-free options, endocrine treatment in combination with HER2 targeted therapy should be considered. However, no survival benefit has been demonstrated so far for these combinations compared to taxane and Tz plus Pz. Therefore, induction chemotherapy followed by endocrine treatment and dual blockade is still the preferred option in triple-positive patients who are suitable for chemotherapy (AGO++).

Metastatic Triple-Negative Breast Cancer (Fig. 7)

Fig. 7.

Fig. 7

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Metastatic triple-negative breast cancer.

In triple-negative breast cancer, metastatic recurrence occurs more often than in other breast cancer subtypes, and estrogen receptor- and HER2-directed treatment options are lacking. For adequate treatment, histopathology including analysis of programmed death ligand 1 (PD-L1) expression and testing for germline BRCA mutations is required [42]. In >50% of cases, single-agent or combination chemotherapy are the only treatment options. Based on performance status and need of remission, for first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC), paclitaxel or capecitabine single-agent or combined with bevacizumab, gemcitabine plus cisplatin, or nab-paclitaxel plus carboplatin are recommended (AGO+) [85, 86, 87, 88, 89, 90]. With further progression, any non-cross-resistant second-line chemotherapy can be delivered. Though most mTNBCs are of no special type, diagnosis of metaplastic carcinoma is associated with resistance against chemotherapy and the individual options have to be discussed [91]. If patients with a germline BRCA1/2 mutation (in the neoadjuvant setting approximately 15% of all cases with triple-negative breast cancer) [92] and no PD-L1 expression have been exposed to prior anthracyclines and taxanes, the treatment of choice is PARP inhibition with olaparib or talazoparib (AGO++) [34, 36]. In a stratified analysis, an overall survival advantage was demonstrated if olaparib was given as first-line therapy [34]. When patients get refractory to PARP inhibition, standard chemotherapy as listed above is indicated. In patients with germline BRCA mutation but no prior treatment with anthracyclines and taxanes (e.g., stage IV breast cancer), standard first-line chemotherapy is indicated (AGO++). Some data showed particular efficacy of single-agent carboplatin in patients with germline BRCA mutation (AGO+) [93]. After progressing on first-line chemotherapy, second-line PARP inhibition can be considered. In patients (10–35%) with wild-type germline BRCA status and PD-L1-positive mTNBC (positive immune cells covering ≥1% of tumor area), first-line therapy with the immune checkpoint inhibitor atezolizumab in combination with nab-paclitaxel is indicated (AGO+). Of note, although the European Medicine Agency approved atezolizumab without restrictions, the pivotal trial has only included patients who have had no prior chemotherapy or at least a 12-month disease-free interval from the initial (neo)adjuvant therapy [94, 95]. Less efficacy with disease-free interval <12 months has been shown for the PD-1 inhibitor pembrolizumab. In patients with germline BRCA mutation and PD-L1 tumor expression (maximum 6%), both options (olaparib/talazoparib or atezolizumab plus nab-paclitaxel) can be discussed (AGO+) [34, 94, 95]. A crossover should always be considered in case of disease progression. For patients with germline BRCA mutation, single-agent carboplatin may also be an option (AGO+) [44]. Finally, in case of progression on targeted therapy, all patients should be subjected to standard chemotherapy as listed above. Experimental approaches including molecular oncology should be considered.

Conflict of Interest Statement

A. Schneeweiss reports grants from Celgene, Roche, and Abb­Vie, personal fees from Roche, AstraZeneca, Celgene, Pfizer, Novartis, MSD, Tesaro, and Lilly, and travel grants from Roche and Celgene. I. Bauerfeind reports honoraria from Novartis, Celgene, Pfizer, Roche, GSK, and Lilly. T. Fehm reports honoraria from Daiichi Sankyo, Novartis, Roche, Lilly, MSD, HelloHealthcare, Amgen, AstraZeneca, Pfizer, and Olympus. W. Janni reports grants and personal fees from Amgen, AstraZeneca, Daiichi Sankyo, Lilly, MSD, MSB, Novartis, Pfizer, and Roche. C. Thomssen reports honoraria from Amgen, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Lilly, MSD, Mylan, Nanostring, Novartis, Pfizer, Pierre Fabre, Puma, Roche, and Vifor. I. Witzel reports honoraria from Amgen, Celgene, Daiichi Sankyo, Lilly, MSD, Novartis, Pfizer, Roche, and TEVA. A. Wöckel reports personal fees from Amgen, Novartis, Eisai, Celgene, Pfizer, Tesaro, TEVA, Hexal Lilly, Roche, AstraZeneca, Sirtex, MSD, and Genomic Health. V. Müller reports institutional research support from Novartis, Roche, Seattle Genetics, and Genentech, honoraria from Amgen, AstraZeneca, Daiichi Sankyo, Eisai, Pfizer, MSD, Novartis, Roche, Teva, Seattle Genetics, Genomic Health, Hexal, Pierre Fabre, Amgen, ClinSol, MSD, Lilly, Tesaro, and Nektar, and travel grants from Roche, Pfizer, and Daiichi Sankyo.

Funding Sources

No funding was received for the preparation of this review.

Author Contributions

All authors substantially contributed to conception and design of the review, to acquisition, analysis, and interpretation of the underlying database, to drafting and critical revising of the intellectual content, and to final approval of the version to be published. All authors agree to be accountable for all aspects of the review in ensuring that questions related to the accuracy or integrity of any part of the review are appropriately investigated and resolved.

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